id	sid	tid	token	lemma	pos
globalce-210	1	1	11	11	NUM
globalce-210	1	2	j	j	PROPN
globalce-210	1	3	global	global	ADJ
globalce-210	1	4	clinical	clinical	ADJ
globalce-210	1	5	engineering	engineering	NOUN
globalce-210	1	6	vol.7	vol.7	PROPN
globalce-210	1	7	issue	issue	NOUN
globalce-210	1	8	2	2	NUM
globalce-210	1	9	:	:	SYM
globalce-210	1	10	2025	2025	NUM
globalce-210	1	11	received	receive	VERB
globalce-210	1	12	july	july	PROPN
globalce-210	1	13	31	31	NUM
globalce-210	1	14	,	,	PUNCT
globalce-210	1	15	2024	2024	NUM
globalce-210	1	16	,	,	PUNCT
globalce-210	1	17	accepted	accept	VERB
globalce-210	1	18	march	march	NOUN
globalce-210	1	19	4	4	NUM
globalce-210	1	20	,	,	PUNCT
globalce-210	1	21	2025	2025	NUM
globalce-210	1	22	,	,	PUNCT
globalce-210	1	23	date	date	NOUN
globalce-210	1	24	of	of	ADP
globalce-210	1	25	publication	publication	NOUN
globalce-210	1	26	april	april	PROPN
globalce-210	1	27	11	11	NUM
globalce-210	1	28	2025	2025	NUM
globalce-210	1	29	.	.	PUNCT
globalce-210	2	1	review	review	VERB
globalce-210	2	2	artificial	artificial	ADJ
globalce-210	2	3	intelligence	intelligence	NOUN
globalce-210	2	4	-	-	PUNCT
globalce-210	2	5	driven	drive	VERB
globalce-210	2	6	insights	insight	NOUN
globalce-210	2	7	for	for	ADP
globalce-210	2	8	regulatory	regulatory	ADJ
globalce-210	2	9	intelligence	intelligence	NOUN
globalce-210	2	10	in	in	ADP
globalce-210	2	11	medical	medical	ADJ
globalce-210	2	12	devices	device	NOUN
globalce-210	2	13	:	:	PUNCT
globalce-210	2	14	evaluating	evaluate	VERB
globalce-210	2	15	ema	ema	PROPN
globalce-210	2	16	,	,	PUNCT
globalce-210	2	17	fda	fda	PROPN
globalce-210	2	18	,	,	PUNCT
globalce-210	2	19	and	and	CCONJ
globalce-210	2	20	cdsco	cdsco	PROPN
globalce-210	2	21	frameworks	framework	NOUN
globalce-210	2	22	radhakrishan	radhakrishan	PROPN
globalce-210	2	23	gaur1	gaur1	PROPN
globalce-210	2	24	,	,	PUNCT
globalce-210	2	25	afifa	afifa	PROPN
globalce-210	2	26	akram1	akram1	PROPN
globalce-210	2	27	,	,	PUNCT
globalce-210	2	28	indu	indu	NOUN
globalce-210	2	29	singh2	singh2	ADJ
globalce-210	2	30	and	and	CCONJ
globalce-210	2	31	shikha	shikha	PROPN
globalce-210	2	32	baghel	baghel	PROPN
globalce-210	2	33	chauhan3	chauhan3	PROPN
globalce-210	2	34	*	*	SYM
globalce-210	2	35	1	1	NUM
globalce-210	2	36	department	department	NOUN
globalce-210	2	37	of	of	ADP
globalce-210	2	38	drug	drug	NOUN
globalce-210	2	39	regulatory	regulatory	ADJ
globalce-210	2	40	affairs	affair	NOUN
globalce-210	2	41	,	,	PUNCT
globalce-210	2	42	amity	amity	NOUN
globalce-210	2	43	institute	institute	PROPN
globalce-210	2	44	of	of	ADP
globalce-210	2	45	pharmacy	pharmacy	NOUN
globalce-210	2	46	,	,	PUNCT
globalce-210	2	47	amity	amity	NOUN
globalce-210	2	48	institute	institute	PROPN
globalce-210	2	49	of	of	ADP
globalce-210	2	50	pharmacy	pharmacy	NOUN
globalce-210	2	51	,	,	PUNCT
globalce-210	2	52	amity	amity	NOUN
globalce-210	2	53	university	university	PROPN
globalce-210	2	54	,	,	PUNCT
globalce-210	2	55	noida	noida	PROPN
globalce-210	2	56	,	,	PUNCT
globalce-210	2	57	up-201301	up-201301	PROPN
globalce-210	2	58	,	,	PUNCT
globalce-210	2	59	india	india	PROPN
globalce-210	2	60	.	.	PROPN
globalce-210	2	61	2	2	NUM
globalce-210	2	62	department	department	NOUN
globalce-210	2	63	of	of	ADP
globalce-210	2	64	pharmaceutics	pharmaceutic	NOUN
globalce-210	2	65	,	,	PUNCT
globalce-210	2	66	amity	amity	NOUN
globalce-210	2	67	institute	institute	NOUN
globalce-210	2	68	of	of	ADP
globalce-210	2	69	pharmacy	pharmacy	NOUN
globalce-210	2	70	,	,	PUNCT
globalce-210	2	71	amity	amity	NOUN
globalce-210	2	72	university	university	PROPN
globalce-210	2	73	,	,	PUNCT
globalce-210	2	74	noida	noida	PROPN
globalce-210	2	75	,	,	PUNCT
globalce-210	2	76	up-201301	up-201301	PROPN
globalce-210	2	77	,	,	PUNCT
globalce-210	2	78	india	india	PROPN
globalce-210	2	79	.	.	PROPN
globalce-210	2	80	3	3	NUM
globalce-210	2	81	department	department	NOUN
globalce-210	2	82	of	of	ADP
globalce-210	2	83	industrial	industrial	ADJ
globalce-210	2	84	pharmacy	pharmacy	NOUN
globalce-210	2	85	,	,	PUNCT
globalce-210	2	86	amity	amity	NOUN
globalce-210	2	87	institute	institute	PROPN
globalce-210	2	88	of	of	ADP
globalce-210	2	89	pharmacy	pharmacy	NOUN
globalce-210	2	90	,	,	PUNCT
globalce-210	2	91	amity	amity	NOUN
globalce-210	2	92	university	university	PROPN
globalce-210	2	93	,	,	PUNCT
globalce-210	2	94	noida	noida	PROPN
globalce-210	2	95	,	,	PUNCT
globalce-210	2	96	up-201301	up-201301	PROPN
globalce-210	2	97	,	,	PUNCT
globalce-210	2	98	india	india	PROPN
globalce-210	2	99	.	.	PUNCT
globalce-210	3	1	*	*	PUNCT
globalce-210	3	2	corresponding	correspond	VERB
globalce-210	3	3	author	author	NOUN
globalce-210	3	4	email	email	NOUN
globalce-210	3	5	:	:	PUNCT
globalce-210	3	6	schauhan@amity.edu	schauhan@amity.edu	VERB
globalce-210	4	1	abstract	abstract	ADJ
globalce-210	4	2	the	the	DET
globalce-210	4	3	current	current	ADJ
globalce-210	4	4	review	review	NOUN
globalce-210	4	5	elaborates	elaborate	VERB
globalce-210	4	6	artificial	artificial	ADJ
globalce-210	4	7	intelligence	intelligence	NOUN
globalce-210	4	8	(	(	PUNCT
globalce-210	4	9	ai	ai	NOUN
globalce-210	4	10	)	)	PUNCT
globalce-210	4	11	in	in	ADP
globalce-210	4	12	medical	medical	ADJ
globalce-210	4	13	devices	device	NOUN
globalce-210	4	14	is	be	AUX
globalce-210	4	15	changing	change	VERB
globalce-210	4	16	the	the	DET
globalce-210	4	17	landscape	landscape	NOUN
globalce-210	4	18	of	of	ADP
globalce-210	4	19	diagnostics	diagnostic	NOUN
globalce-210	4	20	allowing	allow	VERB
globalce-210	4	21	for	for	ADP
globalce-210	4	22	more	more	ADV
globalce-210	4	23	accurate	accurate	ADJ
globalce-210	4	24	and	and	CCONJ
globalce-210	4	25	efficacious	efficacious	ADJ
globalce-210	4	26	treatments	treatment	NOUN
globalce-210	4	27	leading	lead	VERB
globalce-210	4	28	to	to	ADP
globalce-210	4	29	better	well	ADJ
globalce-210	4	30	patient	patient	ADJ
globalce-210	4	31	care	care	NOUN
globalce-210	4	32	.	.	PUNCT
globalce-210	5	1	an	an	DET
globalce-210	5	2	overview	overview	NOUN
globalce-210	5	3	of	of	ADP
globalce-210	5	4	ai	ai	PROPN
globalce-210	5	5	technologies	technology	NOUN
globalce-210	5	6	and	and	CCONJ
globalce-210	5	7	their	their	PRON
globalce-210	5	8	application	application	NOUN
globalce-210	5	9	in	in	ADP
globalce-210	5	10	medical	medical	ADJ
globalce-210	5	11	devices	device	NOUN
globalce-210	5	12	elaborates	elaborate	VERB
globalce-210	5	13	on	on	ADP
globalce-210	5	14	ai	ai	PROPN
globalce-210	5	15	technologies	technology	NOUN
globalce-210	5	16	,	,	PUNCT
globalce-210	5	17	such	such	ADJ
globalce-210	5	18	as	as	ADP
globalce-210	5	19	neural	neural	ADJ
globalce-210	5	20	networks	network	NOUN
globalce-210	5	21	and	and	CCONJ
globalce-210	5	22	advanced	advanced	ADJ
globalce-210	5	23	data	datum	NOUN
globalce-210	5	24	analytics	analytic	NOUN
globalce-210	5	25	being	be	AUX
globalce-210	5	26	applied	apply	VERB
globalce-210	5	27	in	in	ADP
globalce-210	5	28	diagnostic	diagnostic	ADJ
globalce-210	5	29	imaging	imaging	NOUN
globalce-210	5	30	and	and	CCONJ
globalce-210	5	31	patient	patient	NOUN
globalce-210	5	32	-	-	PUNCT
globalce-210	5	33	monitoring	monitor	VERB
globalce-210	5	34	preventative	preventative	ADJ
globalce-210	5	35	analytic	analytic	ADJ
globalce-210	5	36	models	model	NOUN
globalce-210	5	37	.	.	PUNCT
globalce-210	6	1	machine	machine	NOUN
globalce-210	6	2	learning	learning	PROPN
globalce-210	6	3	,	,	PUNCT
globalce-210	6	4	a	a	DET
globalce-210	6	5	subset	subset	NOUN
globalce-210	6	6	of	of	ADP
globalce-210	6	7	ai	ai	PROPN
globalce-210	6	8	,	,	PUNCT
globalce-210	6	9	enables	enable	VERB
globalce-210	6	10	devices	device	NOUN
globalce-210	6	11	to	to	PART
globalce-210	6	12	learn	learn	VERB
globalce-210	6	13	from	from	ADP
globalce-210	6	14	data	datum	NOUN
globalce-210	6	15	and	and	CCONJ
globalce-210	6	16	improve	improve	VERB
globalce-210	6	17	their	their	PRON
globalce-210	6	18	performance	performance	NOUN
globalce-210	6	19	over	over	ADP
globalce-210	6	20	time	time	NOUN
globalce-210	6	21	,	,	PUNCT
globalce-210	6	22	enhancing	enhance	VERB
globalce-210	6	23	diagnostic	diagnostic	ADJ
globalce-210	6	24	accuracy	accuracy	NOUN
globalce-210	6	25	and	and	CCONJ
globalce-210	6	26	personalized	personalized	ADJ
globalce-210	6	27	treatment	treatment	NOUN
globalce-210	6	28	plans	plan	NOUN
globalce-210	6	29	.	.	PUNCT
globalce-210	7	1	an	an	DET
globalce-210	7	2	elaborated	elaborate	VERB
globalce-210	7	3	critical	critical	ADJ
globalce-210	7	4	review	review	NOUN
globalce-210	7	5	is	be	AUX
globalce-210	7	6	presented	present	VERB
globalce-210	7	7	for	for	ADP
globalce-210	7	8	the	the	DET
globalce-210	7	9	regulatory	regulatory	ADJ
globalce-210	7	10	strategies	strategy	NOUN
globalce-210	7	11	implemented	implement	VERB
globalce-210	7	12	by	by	ADP
globalce-210	7	13	relevant	relevant	ADJ
globalce-210	7	14	global	global	ADJ
globalce-210	7	15	leaders	leader	NOUN
globalce-210	7	16	,	,	PUNCT
globalce-210	7	17	such	such	ADJ
globalce-210	7	18	as	as	ADP
globalce-210	7	19	the	the	DET
globalce-210	7	20	european	european	PROPN
globalce-210	7	21	union	union	PROPN
globalce-210	7	22	(	(	PUNCT
globalce-210	7	23	eu	eu	PROPN
globalce-210	7	24	)	)	PUNCT
globalce-210	7	25	,	,	PUNCT
globalce-210	7	26	the	the	DET
globalce-210	7	27	united	united	PROPN
globalce-210	7	28	states	states	PROPN
globalce-210	7	29	(	(	PUNCT
globalce-210	7	30	us	us	PROPN
globalce-210	7	31	food	food	NOUN
globalce-210	7	32	and	and	CCONJ
globalce-210	7	33	drug	drug	PROPN
globalce-210	7	34	administration	administration	PROPN
globalce-210	7	35	,	,	PUNCT
globalce-210	7	36	fda	fda	PROPN
globalce-210	7	37	)	)	PUNCT
globalce-210	7	38	,	,	PUNCT
globalce-210	7	39	and	and	CCONJ
globalce-210	7	40	india	india	PROPN
globalce-210	7	41	(	(	PUNCT
globalce-210	7	42	central	central	ADJ
globalce-210	7	43	drugs	drug	NOUN
globalce-210	7	44	standard	standard	PROPN
globalce-210	7	45	control	control	PROPN
globalce-210	7	46	organization	organization	PROPN
globalce-210	7	47	of	of	ADP
globalce-210	7	48	india	india	PROPN
globalce-210	7	49	,	,	PUNCT
globalce-210	7	50	cdsco	cdsco	PROPN
globalce-210	7	51	)	)	PUNCT
globalce-210	7	52	.	.	PUNCT
globalce-210	8	1	this	this	PRON
globalce-210	8	2	is	be	AUX
globalce-210	8	3	indicative	indicative	ADJ
globalce-210	8	4	of	of	ADP
globalce-210	8	5	the	the	DET
globalce-210	8	6	eu	eu	PROPN
globalce-210	8	7	regulatory	regulatory	ADJ
globalce-210	8	8	approach	approach	NOUN
globalce-210	8	9	as	as	SCONJ
globalce-210	8	10	observed	observe	VERB
globalce-210	8	11	through	through	ADP
globalce-210	8	12	reflection	reflection	NOUN
globalce-210	8	13	paper	paper	NOUN
globalce-210	8	14	by	by	ADP
globalce-210	8	15	the	the	DET
globalce-210	8	16	european	european	PROPN
globalce-210	8	17	medicines	medicines	PROPN
globalce-210	8	18	agency	agency	NOUN
globalce-210	8	19	(	(	PUNCT
globalce-210	8	20	ema	ema	PROPN
globalce-210	8	21	)	)	PUNCT
globalce-210	8	22	on	on	ADP
globalce-210	8	23	a	a	DET
globalce-210	8	24	methodology	methodology	NOUN
globalce-210	8	25	to	to	PART
globalce-210	8	26	assess	assess	VERB
globalce-210	8	27	ai	ai	NOUN
globalce-210	8	28	technologies	technology	NOUN
globalce-210	8	29	used	use	VERB
globalce-210	8	30	in	in	ADP
globalce-210	8	31	conjunction	conjunction	NOUN
globalce-210	8	32	with	with	ADP
globalce-210	8	33	medicinal	medicinal	ADJ
globalce-210	8	34	products	product	NOUN
globalce-210	8	35	,	,	PUNCT
globalce-210	8	36	and	and	CCONJ
globalce-210	8	37	the	the	DET
globalce-210	8	38	software	software	NOUN
globalce-210	8	39	as	as	ADP
globalce-210	8	40	a	a	DET
globalce-210	8	41	medical	medical	ADJ
globalce-210	8	42	device	device	NOUN
globalce-210	8	43	(	(	PUNCT
globalce-210	8	44	samd	samd	ADJ
globalce-210	8	45	)	)	PUNCT
globalce-210	8	46	guideline	guideline	NOUN
globalce-210	8	47	by	by	ADP
globalce-210	8	48	the	the	DET
globalce-210	8	49	fda	fda	PROPN
globalce-210	8	50	in	in	ADP
globalce-210	8	51	the	the	DET
globalce-210	8	52	united	united	PROPN
globalce-210	8	53	states	states	PROPN
globalce-210	8	54	.	.	PUNCT
globalce-210	9	1	the	the	DET
globalce-210	9	2	discussion	discussion	NOUN
globalce-210	9	3	is	be	AUX
globalce-210	9	4	on	on	ADP
globalce-210	9	5	adaptive	adaptive	ADJ
globalce-210	9	6	regulatory	regulatory	ADJ
globalce-210	9	7	strategies	strategy	NOUN
globalce-210	9	8	,	,	PUNCT
globalce-210	9	9	an	an	DET
globalce-210	9	10	overview	overview	NOUN
globalce-210	9	11	of	of	ADP
globalce-210	9	12	some	some	DET
globalce-210	9	13	pre	pre	ADJ
globalce-210	9	14	-	-	ADJ
globalce-210	9	15	certification	certification	ADJ
globalce-210	9	16	programs	program	NOUN
globalce-210	9	17	,	,	PUNCT
globalce-210	9	18	and	and	CCONJ
globalce-210	9	19	detailed	detailed	ADJ
globalce-210	9	20	advice	advice	NOUN
globalce-210	9	21	to	to	ADP
globalce-210	9	22	manufacturers	manufacturer	NOUN
globalce-210	9	23	about	about	ADP
globalce-210	9	24	compliance	compliance	NOUN
globalce-210	9	25	with	with	ADP
globalce-210	9	26	the	the	DET
globalce-210	9	27	processes	process	NOUN
globalce-210	9	28	.	.	PUNCT
globalce-210	10	1	also	also	ADV
globalce-210	10	2	,	,	PUNCT
globalce-210	10	3	india	india	PROPN
globalce-210	10	4	aligning	align	VERB
globalce-210	10	5	with	with	ADP
globalce-210	10	6	the	the	DET
globalce-210	10	7	international	international	ADJ
globalce-210	10	8	medical	medical	ADJ
globalce-210	10	9	device	device	NOUN
globalce-210	10	10	regulators	regulator	NOUN
globalce-210	10	11	forum	forum	NOUN
globalce-210	10	12	(	(	PUNCT
globalce-210	10	13	imdrf	imdrf	PROPN
globalce-210	10	14	)	)	PUNCT
globalce-210	10	15	guidelines	guideline	NOUN
globalce-210	10	16	shows	show	VERB
globalce-210	10	17	its	its	PRON
globalce-210	10	18	appetite	appetite	NOUN
globalce-210	10	19	to	to	PART
globalce-210	10	20	help	help	VERB
globalce-210	10	21	build	build	VERB
globalce-210	10	22	an	an	DET
globalce-210	10	23	extensive	extensive	ADJ
globalce-210	10	24	regulatory	regulatory	ADJ
globalce-210	10	25	framework	framework	NOUN
globalce-210	10	26	for	for	ADP
globalce-210	10	27	ai	ai	ADJ
globalce-210	10	28	-	-	PUNCT
globalce-210	10	29	powered	power	VERB
globalce-210	10	30	medical	medical	ADJ
globalce-210	10	31	devices	device	NOUN
globalce-210	10	32	.	.	PUNCT
globalce-210	11	1	the	the	DET
globalce-210	11	2	current	current	ADJ
globalce-210	11	3	review	review	NOUN
globalce-210	11	4	concludes	conclude	VERB
globalce-210	11	5	by	by	ADP
globalce-210	11	6	highlighting	highlight	VERB
globalce-210	11	7	the	the	DET
globalce-210	11	8	need	need	NOUN
globalce-210	11	9	for	for	ADP
globalce-210	11	10	continued	continue	VERB
globalce-210	11	11	coordination	coordination	NOUN
globalce-210	11	12	between	between	ADP
globalce-210	11	13	regulators	regulator	NOUN
globalce-210	11	14	,	,	PUNCT
globalce-210	11	15	manufacturers	manufacturer	NOUN
globalce-210	11	16	,	,	PUNCT
globalce-210	11	17	and	and	CCONJ
globalce-210	11	18	healthcare	healthcare	NOUN
globalce-210	11	19	players	player	NOUN
globalce-210	11	20	so	so	SCONJ
globalce-210	11	21	that	that	SCONJ
globalce-210	11	22	ai	ai	VERB
globalce-210	11	23	advances	advance	NOUN
globalce-210	11	24	are	be	AUX
globalce-210	11	25	safe	safe	ADJ
globalce-210	11	26	and	and	CCONJ
globalce-210	11	27	adherent	adherent	ADJ
globalce-210	11	28	to	to	ADP
globalce-210	11	29	the	the	DET
globalce-210	11	30	regulations	regulation	NOUN
globalce-210	11	31	that	that	PRON
globalce-210	11	32	improve	improve	VERB
globalce-210	11	33	overall	overall	ADJ
globalce-210	11	34	patient	patient	ADJ
globalce-210	11	35	care	care	NOUN
globalce-210	11	36	.	.	PUNCT
globalce-210	12	1	keywords	keyword	NOUN
globalce-210	12	2	—	—	PUNCT
globalce-210	12	3	regulatory	regulatory	ADJ
globalce-210	12	4	framework	framework	NOUN
globalce-210	12	5	,	,	PUNCT
globalce-210	12	6	patient	patient	ADJ
globalce-210	12	7	monitoring	monitoring	NOUN
globalce-210	12	8	,	,	PUNCT
globalce-210	12	9	diagnostics	diagnostic	NOUN
globalce-210	12	10	,	,	PUNCT
globalce-210	12	11	neural	neural	ADJ
globalce-210	12	12	networks	network	NOUN
globalce-210	12	13	,	,	PUNCT
globalce-210	12	14	machine	machine	NOUN
globalce-210	12	15	learning	learning	NOUN
globalce-210	12	16	.	.	PUNCT
globalce-210	13	1	copyright	copyright	NOUN
globalce-210	13	2	©	©	PROPN
globalce-210	13	3	2025	2025	NUM
globalce-210	13	4	.	.	PUNCT
globalce-210	14	1	this	this	PRON
globalce-210	14	2	is	be	AUX
globalce-210	14	3	an	an	DET
globalce-210	14	4	open	open	ADJ
globalce-210	14	5	-	-	PUNCT
globalce-210	14	6	access	access	NOUN
globalce-210	14	7	article	article	NOUN
globalce-210	14	8	distributed	distribute	VERB
globalce-210	14	9	under	under	ADP
globalce-210	14	10	the	the	DET
globalce-210	14	11	terms	term	NOUN
globalce-210	14	12	of	of	ADP
globalce-210	14	13	the	the	DET
globalce-210	14	14	creative	creative	ADJ
globalce-210	14	15	commons	common	NOUN
globalce-210	14	16	attribution	attribution	NOUN
globalce-210	14	17	license	license	NOUN
globalce-210	14	18	(	(	PUNCT
globalce-210	14	19	cc	cc	NOUN
globalce-210	14	20	by	by	ADV
globalce-210	14	21	):	):	PUNCT
globalce-210	14	22	creative	creative	ADJ
globalce-210	14	23	commons	common	NOUN
globalce-210	14	24	attribution	attribution	NOUN
globalce-210	14	25	4.0	4.0	NUM
globalce-210	14	26	international	international	NOUN
globalce-210	14	27	cc	cc	NOUN
globalce-210	14	28	by	by	ADP
globalce-210	14	29	4.0	4.0	NUM
globalce-210	14	30	.	.	PUNCT
globalce-210	15	1	the	the	DET
globalce-210	15	2	use	use	NOUN
globalce-210	15	3	,	,	PUNCT
globalce-210	15	4	distribution	distribution	NOUN
globalce-210	15	5	or	or	CCONJ
globalce-210	15	6	reproduction	reproduction	NOUN
globalce-210	15	7	in	in	ADP
globalce-210	15	8	other	other	ADJ
globalce-210	15	9	forums	forum	NOUN
globalce-210	15	10	is	be	AUX
globalce-210	15	11	permitted	permit	VERB
globalce-210	15	12	,	,	PUNCT
globalce-210	15	13	provided	provide	VERB
globalce-210	15	14	the	the	DET
globalce-210	15	15	original	original	ADJ
globalce-210	15	16	author(s	author(s	NOUN
globalce-210	15	17	)	)	PUNCT
globalce-210	15	18	and	and	CCONJ
globalce-210	15	19	the	the	DET
globalce-210	15	20	copyright	copyright	NOUN
globalce-210	15	21	owner(s	owner(s	NOUN
globalce-210	15	22	)	)	PUNCT
globalce-210	15	23	are	be	AUX
globalce-210	15	24	credited	credit	VERB
globalce-210	15	25	and	and	CCONJ
globalce-210	15	26	that	that	SCONJ
globalce-210	15	27	the	the	DET
globalce-210	15	28	original	original	ADJ
globalce-210	15	29	publication	publication	NOUN
globalce-210	15	30	in	in	ADP
globalce-210	15	31	this	this	DET
globalce-210	15	32	journal	journal	NOUN
globalce-210	15	33	is	be	AUX
globalce-210	15	34	cited	cite	VERB
globalce-210	15	35	,	,	PUNCT
globalce-210	15	36	in	in	ADP
globalce-210	15	37	accordance	accordance	NOUN
globalce-210	15	38	with	with	ADP
globalce-210	15	39	accepted	accept	VERB
globalce-210	15	40	academic	academic	ADJ
globalce-210	15	41	practice	practice	NOUN
globalce-210	15	42	.	.	PUNCT
globalce-210	16	1	no	no	DET
globalce-210	16	2	use	use	NOUN
globalce-210	16	3	,	,	PUNCT
globalce-210	16	4	distribution	distribution	NOUN
globalce-210	16	5	or	or	CCONJ
globalce-210	16	6	reproduction	reproduction	NOUN
globalce-210	16	7	is	be	AUX
globalce-210	16	8	permitted	permit	VERB
globalce-210	16	9	which	which	PRON
globalce-210	16	10	does	do	AUX
globalce-210	16	11	not	not	PART
globalce-210	16	12	comply	comply	VERB
globalce-210	16	13	with	with	ADP
globalce-210	16	14	these	these	DET
globalce-210	16	15	terms	term	NOUN
globalce-210	16	16	.	.	PUNCT
globalce-210	16	17	http://www.globalce.org	http://www.globalce.org	PUNCT
globalce-210	17	1	http://globalce.org	http://globalce.org	PROPN
globalce-210	17	2	http://globalce.org	http://globalce.org	PROPN
globalce-210	17	3	mailto:schauhan@amity.edu	mailto:schauhan@amity.edu	PROPN
globalce-210	17	4	https://creativecommons.org/licenses/by/4.0/	https://creativecommons.org/licenses/by/4.0/	PROPN
globalce-210	17	5	https://creativecommons.org/licenses/by/4.0/	https://creativecommons.org/licenses/by/4.0/	PROPN
globalce-210	17	6	gaur	gaur	PROPN
globalce-210	17	7	,	,	PUNCT
globalce-210	17	8	akram	akram	PROPN
globalce-210	17	9	,	,	PUNCT
globalce-210	17	10	singh	singh	PROPN
globalce-210	17	11	,	,	PUNCT
globalce-210	17	12	chauhan	chauhan	PROPN
globalce-210	17	13	:	:	PUNCT
globalce-210	17	14	artificial	artificial	ADJ
globalce-210	17	15	intelligence	intelligence	NOUN
globalce-210	17	16	-	-	PUNCT
globalce-210	17	17	driven	drive	VERB
globalce-210	17	18	insights	insight	NOUN
globalce-210	17	19	for	for	ADP
globalce-210	17	20	regulatory	regulatory	ADJ
globalce-210	17	21	intelligence	intelligence	NOUN
globalce-210	17	22	in	in	ADP
globalce-210	17	23	medical	medical	ADJ
globalce-210	17	24	devices	device	NOUN
globalce-210	17	25	:	:	PUNCT
globalce-210	17	26	evaluating	evaluate	VERB
globalce-210	17	27	ema	ema	PROPN
globalce-210	17	28	,	,	PUNCT
globalce-210	17	29	fda	fda	PROPN
globalce-210	17	30	,	,	PUNCT
globalce-210	17	31	and	and	CCONJ
globalce-210	17	32	cdsco	cdsco	PROPN
globalce-210	17	33	frameworks	framework	VERB
globalce-210	17	34	j	j	PROPN
globalce-210	17	35	global	global	ADJ
globalce-210	17	36	clinical	clinical	ADJ
globalce-210	17	37	engineering	engineering	NOUN
globalce-210	17	38	vol.7	vol.7	PROPN
globalce-210	17	39	issue	issue	NOUN
globalce-210	17	40	2	2	NUM
globalce-210	17	41	:	:	SYM
globalce-210	17	42	2025	2025	NUM
globalce-210	17	43	12	12	NUM
globalce-210	17	44	introduction	introduction	NOUN
globalce-210	17	45	the	the	DET
globalce-210	17	46	medical	medical	ADJ
globalce-210	17	47	device	device	NOUN
globalce-210	17	48	industry	industry	NOUN
globalce-210	17	49	is	be	AUX
globalce-210	17	50	being	be	AUX
globalce-210	17	51	revolutionized	revolutionize	VERB
globalce-210	17	52	by	by	ADP
globalce-210	17	53	artificial	artificial	ADJ
globalce-210	17	54	intelligence	intelligence	NOUN
globalce-210	17	55	(	(	PUNCT
globalce-210	17	56	ai	ai	VERB
globalce-210	17	57	)	)	PUNCT
globalce-210	17	58	through	through	ADP
globalce-210	17	59	more	more	ADV
globalce-210	17	60	efficient	efficient	ADJ
globalce-210	17	61	,	,	PUNCT
globalce-210	17	62	datadriven	datadriven	ADJ
globalce-210	17	63	,	,	PUNCT
globalce-210	17	64	and	and	CCONJ
globalce-210	17	65	adaptive	adaptive	ADJ
globalce-210	17	66	regulatory	regulatory	ADJ
globalce-210	17	67	practices	practice	NOUN
globalce-210	17	68	.	.	PUNCT
globalce-210	18	1	to	to	PART
globalce-210	18	2	improve	improve	VERB
globalce-210	18	3	processes	process	NOUN
globalce-210	18	4	,	,	PUNCT
globalce-210	18	5	decision	decision	NOUN
globalce-210	18	6	-	-	PUNCT
globalce-210	18	7	making	make	VERB
globalce-210	18	8	ability	ability	NOUN
globalce-210	18	9	,	,	PUNCT
globalce-210	18	10	and	and	CCONJ
globalce-210	18	11	quality	quality	NOUN
globalce-210	18	12	of	of	ADP
globalce-210	18	13	healthcare	healthcare	NOUN
globalce-210	18	14	provision	provision	NOUN
globalce-210	18	15	,	,	PUNCT
globalce-210	18	16	regulatory	regulatory	ADJ
globalce-210	18	17	bodies	body	NOUN
globalce-210	18	18	around	around	ADP
globalce-210	18	19	the	the	DET
globalce-210	18	20	world	world	NOUN
globalce-210	18	21	,	,	PUNCT
globalce-210	18	22	such	such	ADJ
globalce-210	18	23	as	as	ADP
globalce-210	18	24	the	the	DET
globalce-210	18	25	european	european	PROPN
globalce-210	18	26	union	union	PROPN
globalce-210	18	27	(	(	PUNCT
globalce-210	18	28	eu	eu	PROPN
globalce-210	18	29	)	)	PUNCT
globalce-210	18	30	,	,	PUNCT
globalce-210	18	31	us	us	PROPN
globalce-210	18	32	food	food	NOUN
globalce-210	18	33	and	and	CCONJ
globalce-210	18	34	drug	drug	PROPN
globalce-210	18	35	administration	administration	NOUN
globalce-210	18	36	(	(	PUNCT
globalce-210	18	37	us	us	PROPN
globalce-210	18	38	fda	fda	PROPN
globalce-210	18	39	)	)	PUNCT
globalce-210	18	40	,	,	PUNCT
globalce-210	18	41	and	and	CCONJ
globalce-210	18	42	central	central	ADJ
globalce-210	18	43	drugs	drug	NOUN
globalce-210	18	44	standard	standard	PROPN
globalce-210	18	45	control	control	PROPN
globalce-210	18	46	organization	organization	NOUN
globalce-210	18	47	of	of	ADP
globalce-210	18	48	india	india	PROPN
globalce-210	18	49	(	(	PUNCT
globalce-210	18	50	cdsco	cdsco	PROPN
globalce-210	18	51	)	)	PUNCT
globalce-210	18	52	,	,	PUNCT
globalce-210	18	53	are	be	AUX
globalce-210	18	54	employing	employ	VERB
globalce-210	18	55	ai	ai	NOUN
globalce-210	18	56	-	-	PUNCT
globalce-210	18	57	based	base	VERB
globalce-210	18	58	technologies	technology	NOUN
globalce-210	18	59	.	.	PUNCT
globalce-210	19	1	ai	ai	VERB
globalce-210	19	2	-	-	PUNCT
globalce-210	19	3	driven	drive	VERB
globalce-210	19	4	medical	medical	ADJ
globalce-210	19	5	devices	device	NOUN
globalce-210	19	6	extract	extract	VERB
globalce-210	19	7	valuable	valuable	ADJ
globalce-210	19	8	insights	insight	NOUN
globalce-210	19	9	from	from	ADP
globalce-210	19	10	medical	medical	ADJ
globalce-210	19	11	data	datum	NOUN
globalce-210	19	12	by	by	ADP
globalce-210	19	13	using	use	VERB
globalce-210	19	14	advanced	advanced	ADJ
globalce-210	19	15	methods	method	NOUN
globalce-210	19	16	of	of	ADP
globalce-210	19	17	data	datum	NOUN
globalce-210	19	18	analysis	analysis	NOUN
globalce-210	19	19	as	as	ADV
globalce-210	19	20	well	well	ADV
globalce-210	19	21	as	as	ADP
globalce-210	19	22	machine	machine	NOUN
globalce-210	19	23	learning	learning	NOUN
globalce-210	19	24	(	(	PUNCT
globalce-210	19	25	ml	ml	NOUN
globalce-210	19	26	)	)	PUNCT
globalce-210	19	27	algorithms	algorithm	NOUN
globalce-210	19	28	.	.	PUNCT
globalce-210	20	1	they	they	PRON
globalce-210	20	2	then	then	ADV
globalce-210	20	3	assist	assist	VERB
globalce-210	20	4	doctors	doctor	NOUN
globalce-210	20	5	in	in	ADP
globalce-210	20	6	making	make	VERB
globalce-210	20	7	better	well	ADJ
globalce-210	20	8	decisions	decision	NOUN
globalce-210	20	9	,	,	PUNCT
globalce-210	20	10	which	which	PRON
globalce-210	20	11	have	have	VERB
globalce-210	20	12	a	a	DET
globalce-210	20	13	positive	positive	ADJ
globalce-210	20	14	impact	impact	NOUN
globalce-210	20	15	on	on	ADP
globalce-210	20	16	patients	patient	NOUN
globalce-210	20	17	’	’	PART
globalce-210	20	18	health	health	NOUN
globalce-210	20	19	outcomes.1	outcomes.1	PROPN
globalce-210	20	20	however	however	ADV
globalce-210	20	21	,	,	PUNCT
globalce-210	20	22	for	for	ADP
globalce-210	20	23	medical	medical	ADJ
globalce-210	20	24	devices	device	NOUN
globalce-210	20	25	guided	guide	VERB
globalce-210	20	26	by	by	ADP
globalce-210	20	27	ai	ai	VERB
globalce-210	20	28	to	to	PART
globalce-210	20	29	be	be	AUX
globalce-210	20	30	safe	safe	ADJ
globalce-210	20	31	and	and	CCONJ
globalce-210	20	32	efficient	efficient	ADJ
globalce-210	20	33	,	,	PUNCT
globalce-210	20	34	they	they	PRON
globalce-210	20	35	should	should	AUX
globalce-210	20	36	adhere	adhere	VERB
globalce-210	20	37	to	to	ADP
globalce-210	20	38	good	good	ADJ
globalce-210	20	39	machine	machine	NOUN
globalce-210	20	40	learning	learning	NOUN
globalce-210	20	41	practices	practice	NOUN
globalce-210	20	42	(	(	PUNCT
globalce-210	20	43	gmlp	gmlp	ADJ
globalce-210	20	44	)	)	PUNCT
globalce-210	20	45	,	,	PUNCT
globalce-210	20	46	real	real	ADJ
globalce-210	20	47	-	-	PUNCT
globalce-210	20	48	world	world	NOUN
globalce-210	20	49	performance	performance	NOUN
globalce-210	20	50	tracking	tracking	NOUN
globalce-210	20	51	,	,	PUNCT
globalce-210	20	52	compliance	compliance	NOUN
globalce-210	20	53	monitoring	monitoring	NOUN
globalce-210	20	54	,	,	PUNCT
globalce-210	20	55	and	and	CCONJ
globalce-210	20	56	ai	ai	PROPN
globalce-210	20	57	-	-	PUNCT
globalce-210	20	58	ml	ml	NOUN
globalce-210	20	59	software	software	NOUN
globalce-210	20	60	used	use	VERB
globalce-210	20	61	as	as	ADP
globalce-210	20	62	medical	medical	ADJ
globalce-210	20	63	devices	device	NOUN
globalce-210	20	64	.	.	PUNCT
globalce-210	21	1	other	other	ADJ
globalce-210	21	2	essential	essential	ADJ
globalce-210	21	3	components	component	NOUN
globalce-210	21	4	include	include	VERB
globalce-210	21	5	regulatory	regulatory	ADJ
globalce-210	21	6	frameworks	framework	NOUN
globalce-210	21	7	,	,	PUNCT
globalce-210	21	8	ai	ai	NOUN
globalce-210	21	9	-	-	PUNCT
globalce-210	21	10	powered	power	VERB
globalce-210	21	11	regulatory	regulatory	ADJ
globalce-210	21	12	documentation	documentation	NOUN
globalce-210	21	13	,	,	PUNCT
globalce-210	21	14	ai	ai	VERB
globalce-210	21	15	-	-	PUNCT
globalce-210	21	16	assisted	assist	VERB
globalce-210	21	17	regulatory	regulatory	ADJ
globalce-210	21	18	expertise	expertise	NOUN
globalce-210	21	19	,	,	PUNCT
globalce-210	21	20	and	and	CCONJ
globalce-210	21	21	ai	ai	AUX
globalce-210	21	22	-	-	PUNCT
globalce-210	21	23	driven	drive	VERB
globalce-210	21	24	regulatory	regulatory	NOUN
globalce-210	21	25	insights.2	insights.2	VERB
globalce-210	21	26	the	the	DET
globalce-210	21	27	integration	integration	NOUN
globalce-210	21	28	of	of	ADP
globalce-210	21	29	these	these	DET
globalce-210	21	30	elements	element	NOUN
globalce-210	21	31	ensures	ensure	VERB
globalce-210	21	32	that	that	SCONJ
globalce-210	21	33	manufacturers	manufacturer	NOUN
globalce-210	21	34	of	of	ADP
globalce-210	21	35	medical	medical	ADJ
globalce-210	21	36	devices	device	NOUN
globalce-210	21	37	can	can	AUX
globalce-210	21	38	safely	safely	ADV
globalce-210	21	39	and	and	CCONJ
globalce-210	21	40	efficiently	efficiently	ADV
globalce-210	21	41	develop	develop	VERB
globalce-210	21	42	,	,	PUNCT
globalce-210	21	43	test	test	NOUN
globalce-210	21	44	,	,	PUNCT
globalce-210	21	45	and	and	CCONJ
globalce-210	21	46	deploy	deploy	VERB
globalce-210	21	47	ai	ai	ADJ
globalce-210	21	48	-	-	PUNCT
globalce-210	21	49	enabled	enable	VERB
globalce-210	21	50	devices.3	devices.3	PROPN
globalce-210	21	51	this	this	DET
globalce-210	21	52	approach	approach	NOUN
globalce-210	21	53	improves	improve	VERB
globalce-210	21	54	patient	patient	ADJ
globalce-210	21	55	outcomes	outcome	NOUN
globalce-210	21	56	and	and	CCONJ
globalce-210	21	57	enhances	enhance	VERB
globalce-210	21	58	healthcare	healthcare	NOUN
globalce-210	21	59	quality	quality	NOUN
globalce-210	21	60	,	,	PUNCT
globalce-210	21	61	as	as	SCONJ
globalce-210	21	62	it	it	PRON
globalce-210	21	63	affects	affect	VERB
globalce-210	21	64	all	all	DET
globalce-210	21	65	aspects	aspect	NOUN
globalce-210	21	66	of	of	ADP
globalce-210	21	67	health	health	NOUN
globalce-210	21	68	services	service	NOUN
globalce-210	21	69	,	,	PUNCT
globalce-210	21	70	including	include	VERB
globalce-210	21	71	expenses	expense	NOUN
globalce-210	21	72	,	,	PUNCT
globalce-210	21	73	as	as	SCONJ
globalce-210	21	74	we	we	PRON
globalce-210	21	75	observe	observe	VERB
globalce-210	21	76	in	in	ADP
globalce-210	21	77	the	the	DET
globalce-210	21	78	text	text	NOUN
globalce-210	21	79	.	.	PUNCT
globalce-210	22	1	the	the	DET
globalce-210	22	2	fda	fda	PROPN
globalce-210	22	3	is	be	AUX
globalce-210	22	4	at	at	ADP
globalce-210	22	5	the	the	DET
globalce-210	22	6	forefront	forefront	NOUN
globalce-210	22	7	of	of	ADP
globalce-210	22	8	developing	develop	VERB
globalce-210	22	9	guidelines	guideline	NOUN
globalce-210	22	10	for	for	ADP
globalce-210	22	11	evaluating	evaluate	VERB
globalce-210	22	12	the	the	DET
globalce-210	22	13	safety	safety	NOUN
globalce-210	22	14	and	and	CCONJ
globalce-210	22	15	effectiveness	effectiveness	NOUN
globalce-210	22	16	of	of	ADP
globalce-210	22	17	ai	ai	ADJ
globalce-210	22	18	-	-	PUNCT
globalce-210	22	19	enabled	enable	VERB
globalce-210	22	20	medical	medical	ADJ
globalce-210	22	21	devices	device	NOUN
globalce-210	22	22	worldwide	worldwide	ADV
globalce-210	22	23	.	.	PUNCT
globalce-210	23	1	the	the	DET
globalce-210	23	2	use	use	NOUN
globalce-210	23	3	of	of	ADP
globalce-210	23	4	ai	ai	NOUN
globalce-210	23	5	in	in	ADP
globalce-210	23	6	healthcare	healthcare	NOUN
globalce-210	23	7	raises	raise	VERB
globalce-210	23	8	a	a	DET
globalce-210	23	9	number	number	NOUN
globalce-210	23	10	of	of	ADP
globalce-210	23	11	complex	complex	ADJ
globalce-210	23	12	regulatory	regulatory	ADJ
globalce-210	23	13	issues	issue	NOUN
globalce-210	23	14	,	,	PUNCT
globalce-210	23	15	some	some	PRON
globalce-210	23	16	of	of	ADP
globalce-210	23	17	which	which	PRON
globalce-210	23	18	are	be	AUX
globalce-210	23	19	unique	unique	ADJ
globalce-210	23	20	to	to	PART
globalce-210	23	21	ai	ai	VERB
globalce-210	23	22	technology	technology	NOUN
globalce-210	23	23	.	.	PUNCT
globalce-210	24	1	a	a	DET
globalce-210	24	2	key	key	ADJ
globalce-210	24	3	challenge	challenge	NOUN
globalce-210	24	4	is	be	AUX
globalce-210	24	5	the	the	DET
globalce-210	24	6	transparency	transparency	NOUN
globalce-210	24	7	of	of	ADP
globalce-210	24	8	ai	ai	PROPN
globalce-210	24	9	algorithms	algorithm	NOUN
globalce-210	24	10	,	,	PUNCT
globalce-210	24	11	which	which	PRON
globalce-210	24	12	sets	set	VERB
globalce-210	24	13	them	they	PRON
globalce-210	24	14	apart	apart	ADV
globalce-210	24	15	from	from	ADP
globalce-210	24	16	more	more	ADV
globalce-210	24	17	traditional	traditional	ADJ
globalce-210	24	18	regulated	regulated	ADJ
globalce-210	24	19	technologies.4	technologies.4	NOUN
globalce-210	24	20	to	to	PART
globalce-210	24	21	address	address	VERB
globalce-210	24	22	these	these	DET
globalce-210	24	23	challenges	challenge	NOUN
globalce-210	24	24	,	,	PUNCT
globalce-210	24	25	regulatory	regulatory	ADJ
globalce-210	24	26	bodies	body	NOUN
globalce-210	24	27	are	be	AUX
globalce-210	24	28	developing	develop	VERB
globalce-210	24	29	training	training	NOUN
globalce-210	24	30	programs	program	NOUN
globalce-210	24	31	and	and	CCONJ
globalce-210	24	32	guidelines	guideline	NOUN
globalce-210	24	33	to	to	PART
globalce-210	24	34	enhance	enhance	VERB
globalce-210	24	35	regulatory	regulatory	ADJ
globalce-210	24	36	expertise	expertise	NOUN
globalce-210	24	37	in	in	ADP
globalce-210	24	38	ai	ai	PROPN
globalce-210	24	39	and	and	CCONJ
globalce-210	24	40	ml	ml	NOUN
globalce-210	24	41	.	.	NOUN
globalce-210	24	42	overview	overview	NOUN
globalce-210	24	43	of	of	ADP
globalce-210	24	44	artificial	artificial	ADJ
globalce-210	24	45	intelligence	intelligence	NOUN
globalce-210	24	46	in	in	ADP
globalce-210	24	47	medical	medical	ADJ
globalce-210	24	48	devices	device	NOUN
globalce-210	24	49	artificial	artificial	ADJ
globalce-210	24	50	intelligence	intelligence	NOUN
globalce-210	24	51	means	mean	VERB
globalce-210	24	52	a	a	DET
globalce-210	24	53	system	system	NOUN
globalce-210	24	54	that	that	PRON
globalce-210	24	55	acts	act	VERB
globalce-210	24	56	with	with	ADP
globalce-210	24	57	the	the	DET
globalce-210	24	58	help	help	NOUN
globalce-210	24	59	of	of	ADP
globalce-210	24	60	machines	machine	NOUN
globalce-210	24	61	and	and	CCONJ
globalce-210	24	62	predicts	predict	NOUN
globalce-210	24	63	or	or	CCONJ
globalce-210	24	64	suggests	suggest	VERB
globalce-210	24	65	actions	action	NOUN
globalce-210	24	66	in	in	ADP
globalce-210	24	67	real	real	ADJ
globalce-210	24	68	-	-	PUNCT
globalce-210	24	69	world	world	NOUN
globalce-210	24	70	but	but	CCONJ
globalce-210	24	71	potentially	potentially	ADV
globalce-210	24	72	also	also	ADV
globalce-210	24	73	in	in	ADP
globalce-210	24	74	virtual	virtual	ADJ
globalce-210	24	75	environments	environment	NOUN
globalce-210	24	76	according	accord	VERB
globalce-210	24	77	to	to	ADP
globalce-210	24	78	the	the	DET
globalce-210	24	79	objectives	objective	NOUN
globalce-210	24	80	set	set	VERB
globalce-210	24	81	by	by	ADP
globalce-210	24	82	humans	human	NOUN
globalce-210	24	83	.	.	PUNCT
globalce-210	25	1	these	these	DET
globalce-210	25	2	systems	system	NOUN
globalce-210	25	3	require	require	VERB
globalce-210	25	4	both	both	PRON
globalce-210	25	5	ml	ml	NOUN
globalce-210	25	6	and	and	CCONJ
globalce-210	25	7	human	human	NOUN
globalce-210	25	8	-	-	PUNCT
globalce-210	25	9	based	base	VERB
globalce-210	25	10	input	input	NOUN
globalce-210	25	11	to	to	PART
globalce-210	25	12	identify	identify	VERB
globalce-210	25	13	,	,	PUNCT
globalce-210	25	14	translate	translate	VERB
globalce-210	25	15	,	,	PUNCT
globalce-210	25	16	and	and	CCONJ
globalce-210	25	17	create	create	VERB
globalce-210	25	18	the	the	DET
globalce-210	25	19	context	context	NOUN
globalce-210	25	20	around	around	ADV
globalce-210	25	21	,	,	PUNCT
globalce-210	25	22	and	and	CCONJ
globalce-210	25	23	perceive	perceive	ADJ
globalce-210	25	24	real	real	ADJ
globalce-210	25	25	or	or	CCONJ
globalce-210	25	26	fictive	fictive	ADJ
globalce-210	25	27	environments	environment	NOUN
globalce-210	25	28	.	.	PUNCT
globalce-210	26	1	it	it	PRON
globalce-210	26	2	parses	parse	VERB
globalce-210	26	3	these	these	DET
globalce-210	26	4	perceptions	perception	NOUN
globalce-210	26	5	automatically	automatically	ADV
globalce-210	26	6	,	,	PUNCT
globalce-210	26	7	and	and	CCONJ
globalce-210	26	8	then	then	ADV
globalce-210	26	9	abstracts	abstract	VERB
globalce-210	26	10	them	they	PRON
globalce-210	26	11	into	into	ADP
globalce-210	26	12	models	model	NOUN
globalce-210	26	13	.	.	PUNCT
globalce-210	27	1	the	the	DET
globalce-210	27	2	data	datum	NOUN
globalce-210	27	3	are	be	AUX
globalce-210	27	4	then	then	ADV
globalce-210	27	5	leveraged	leverage	VERB
globalce-210	27	6	to	to	PART
globalce-210	27	7	create	create	VERB
globalce-210	27	8	models	model	NOUN
globalce-210	27	9	for	for	ADP
globalce-210	27	10	mining	mining	NOUN
globalce-210	27	11	information	information	NOUN
globalce-210	27	12	,	,	PUNCT
globalce-210	27	13	or	or	CCONJ
globalce-210	27	14	possible	possible	ADJ
globalce-210	27	15	decisions	decision	NOUN
globalce-210	27	16	are	be	AUX
globalce-210	27	17	modeled	model	VERB
globalce-210	27	18	by	by	ADP
globalce-210	27	19	the	the	DET
globalce-210	27	20	process	process	NOUN
globalce-210	27	21	of	of	ADP
globalce-210	27	22	model	model	NOUN
globalce-210	27	23	inference.5	inference.5	SCONJ
globalce-210	27	24	the	the	DET
globalce-210	27	25	applications	application	NOUN
globalce-210	27	26	of	of	ADP
globalce-210	27	27	medical	medical	ADJ
globalce-210	27	28	devices	device	NOUN
globalce-210	27	29	have	have	AUX
globalce-210	27	30	been	be	AUX
globalce-210	27	31	listed	list	VERB
globalce-210	27	32	in	in	ADP
globalce-210	27	33	figure	figure	NOUN
globalce-210	27	34	1	1	NUM
globalce-210	27	35	.	.	PUNCT
globalce-210	28	1	applications	application	NOUN
globalce-210	28	2	of	of	ADP
globalce-210	28	3	ai	ai	NOUN
globalce-210	28	4	in	in	ADP
globalce-210	28	5	medical	medical	ADJ
globalce-210	28	6	devices	device	NOUN
globalce-210	28	7	figure	figure	VERB
globalce-210	28	8	1	1	NUM
globalce-210	28	9	.	.	PUNCT
globalce-210	29	1	application	application	NOUN
globalce-210	29	2	of	of	ADP
globalce-210	29	3	ai	ai	NOUN
globalce-210	29	4	in	in	ADP
globalce-210	29	5	medical	medical	ADJ
globalce-210	29	6	devices	device	NOUN
globalce-210	29	7	.	.	PUNCT
globalce-210	30	1	disease	disease	NOUN
globalce-210	30	2	detection	detection	NOUN
globalce-210	30	3	and	and	CCONJ
globalce-210	30	4	diagnosis	diagnosis	NOUN
globalce-210	30	5	:	:	PUNCT
globalce-210	30	6	ai	ai	VERB
globalce-210	30	7	algorithms	algorithm	NOUN
globalce-210	30	8	,	,	PUNCT
globalce-210	30	9	including	include	VERB
globalce-210	30	10	deep	deep	ADJ
globalce-210	30	11	learning	learning	NOUN
globalce-210	30	12	models	model	NOUN
globalce-210	30	13	such	such	ADJ
globalce-210	30	14	as	as	ADP
globalce-210	30	15	convolutional	convolutional	ADJ
globalce-210	30	16	neural	neural	ADJ
globalce-210	30	17	networks	network	NOUN
globalce-210	30	18	,	,	PUNCT
globalce-210	30	19	can	can	AUX
globalce-210	30	20	help	help	VERB
globalce-210	30	21	doctors	doctor	NOUN
globalce-210	30	22	make	make	VERB
globalce-210	30	23	decisions	decision	NOUN
globalce-210	30	24	in	in	ADP
globalce-210	30	25	many	many	ADJ
globalce-210	30	26	areas	area	NOUN
globalce-210	30	27	of	of	ADP
globalce-210	30	28	medicine	medicine	NOUN
globalce-210	30	29	,	,	PUNCT
globalce-210	30	30	such	such	ADJ
globalce-210	30	31	as	as	ADP
globalce-210	30	32	oncology	oncology	NOUN
globalce-210	30	33	,	,	PUNCT
globalce-210	30	34	radiology	radiology	NOUN
globalce-210	30	35	,	,	PUNCT
globalce-210	30	36	ophthalmology	ophthalmology	NOUN
globalce-210	30	37	,	,	PUNCT
globalce-210	30	38	and	and	CCONJ
globalce-210	30	39	general	general	ADJ
globalce-210	30	40	medicine	medicine	NOUN
globalce-210	30	41	.	.	PUNCT
globalce-210	31	1	these	these	DET
globalce-210	31	2	algorithms	algorithm	NOUN
globalce-210	31	3	analyze	analyze	VERB
globalce-210	31	4	medical	medical	ADJ
globalce-210	31	5	images	image	NOUN
globalce-210	31	6	(	(	PUNCT
globalce-210	31	7	e.g.	e.g.	ADV
globalce-210	31	8	,	,	PUNCT
globalce-210	31	9	mri	mri	NOUN
globalce-210	31	10	,	,	PUNCT
globalce-210	31	11	ct	ct	PROPN
globalce-210	31	12	scans	scan	NOUN
globalce-210	31	13	,	,	PUNCT
globalce-210	31	14	x	x	NOUN
globalce-210	31	15	-	-	NOUN
globalce-210	31	16	rays	ray	NOUN
globalce-210	31	17	,	,	PUNCT
globalce-210	31	18	etc	etc	X
globalce-210	31	19	.	.	X
globalce-210	31	20	)	)	PUNCT
globalce-210	32	1	and	and	CCONJ
globalce-210	32	2	other	other	ADJ
globalce-210	32	3	patient	patient	ADJ
globalce-210	32	4	information	information	NOUN
globalce-210	32	5	to	to	PART
globalce-210	32	6	assist	assist	VERB
globalce-210	32	7	in	in	ADP
globalce-210	32	8	diagnosis	diagnosis	NOUN
globalce-210	32	9	.	.	PUNCT
globalce-210	33	1	studies	study	NOUN
globalce-210	33	2	have	have	AUX
globalce-210	33	3	shown	show	VERB
globalce-210	33	4	that	that	SCONJ
globalce-210	33	5	these	these	DET
globalce-210	33	6	models	model	NOUN
globalce-210	33	7	can	can	AUX
globalce-210	33	8	reduce	reduce	VERB
globalce-210	33	9	waiting	waiting	NOUN
globalce-210	33	10	period	period	NOUN
globalce-210	33	11	,	,	PUNCT
globalce-210	33	12	enhance	enhance	VERB
globalce-210	33	13	medication	medication	NOUN
globalce-210	33	14	compliance	compliance	NOUN
globalce-210	33	15	,	,	PUNCT
globalce-210	33	16	and	and	CCONJ
globalce-210	33	17	tailor	tailor	NOUN
globalce-210	33	18	insulin	insulin	NOUN
globalce-210	33	19	doses	dose	NOUN
globalce-210	33	20	,	,	PUNCT
globalce-210	33	21	among	among	ADP
globalce-210	33	22	other	other	ADJ
globalce-210	33	23	benefits	benefit	NOUN
globalce-210	33	24	.	.	PUNCT
globalce-210	34	1	ai	ai	VERB
globalce-210	34	2	for	for	ADP
globalce-210	34	3	personalized	personalized	ADJ
globalce-210	34	4	medicine	medicine	NOUN
globalce-210	34	5	:	:	PUNCT
globalce-210	34	6	ai	ai	VERB
globalce-210	34	7	tools	tool	NOUN
globalce-210	34	8	can	can	AUX
globalce-210	34	9	recommend	recommend	VERB
globalce-210	34	10	the	the	DET
globalce-210	34	11	most	most	ADV
globalce-210	34	12	effective	effective	ADJ
globalce-210	34	13	treatments	treatment	NOUN
globalce-210	34	14	based	base	VERB
globalce-210	34	15	on	on	ADP
globalce-210	34	16	genetic	genetic	ADJ
globalce-210	34	17	and	and	CCONJ
globalce-210	34	18	medical	medical	ADJ
globalce-210	34	19	history	history	NOUN
globalce-210	34	20	,	,	PUNCT
globalce-210	34	21	as	as	ADV
globalce-210	34	22	well	well	ADV
globalce-210	34	23	as	as	ADP
globalce-210	34	24	lifestyle	lifestyle	NOUN
globalce-210	34	25	factors	factor	NOUN
globalce-210	34	26	,	,	PUNCT
globalce-210	34	27	leading	lead	VERB
globalce-210	34	28	to	to	ADP
globalce-210	34	29	more	more	ADV
globalce-210	34	30	precise	precise	ADJ
globalce-210	34	31	and	and	CCONJ
globalce-210	34	32	effective	effective	ADJ
globalce-210	34	33	treatments	treatment	NOUN
globalce-210	34	34	.	.	PUNCT
globalce-210	35	1	continuous	continuous	ADJ
globalce-210	35	2	learning	learning	NOUN
globalce-210	35	3	and	and	CCONJ
globalce-210	35	4	improvement	improvement	NOUN
globalce-210	35	5	:	:	PUNCT
globalce-210	35	6	ai	ai	AUX
globalce-210	35	7	devices	device	NOUN
globalce-210	35	8	can	can	AUX
globalce-210	35	9	learn	learn	VERB
globalce-210	35	10	from	from	ADP
globalce-210	35	11	real	real	ADJ
globalce-210	35	12	-	-	PUNCT
globalce-210	35	13	world	world	NOUN
globalce-210	35	14	use	use	NOUN
globalce-210	35	15	to	to	PART
globalce-210	35	16	improve	improve	VERB
globalce-210	35	17	their	their	PRON
globalce-210	35	18	performance	performance	NOUN
globalce-210	35	19	over	over	ADP
globalce-210	35	20	time	time	NOUN
globalce-210	35	21	,	,	PUNCT
globalce-210	35	22	adapting	adapt	VERB
globalce-210	35	23	to	to	ADP
globalce-210	35	24	new	new	ADJ
globalce-210	35	25	clinical	clinical	ADJ
globalce-210	35	26	scenarios	scenario	NOUN
globalce-210	35	27	and	and	CCONJ
globalce-210	35	28	enhancing	enhance	VERB
globalce-210	35	29	their	their	PRON
globalce-210	35	30	detection	detection	NOUN
globalce-210	35	31	capabilities	capability	NOUN
globalce-210	35	32	,	,	PUNCT
globalce-210	35	33	which	which	PRON
globalce-210	35	34	in	in	ADP
globalce-210	35	35	turn	turn	NOUN
globalce-210	35	36	improve	improve	VERB
globalce-210	35	37	patient	patient	ADJ
globalce-210	35	38	care	care	NOUN
globalce-210	35	39	.	.	PUNCT
globalce-210	36	1	13	13	NUM
globalce-210	36	2	j	j	PROPN
globalce-210	36	3	global	global	ADJ
globalce-210	36	4	clinical	clinical	ADJ
globalce-210	36	5	engineering	engineering	NOUN
globalce-210	36	6	vol.7	vol.7	PROPN
globalce-210	36	7	issue	issue	NOUN
globalce-210	36	8	2	2	NUM
globalce-210	36	9	:	:	SYM
globalce-210	36	10	2025	2025	NUM
globalce-210	36	11	gaur	gaur	NOUN
globalce-210	36	12	,	,	PUNCT
globalce-210	36	13	akram	akram	PROPN
globalce-210	36	14	,	,	PUNCT
globalce-210	36	15	singh	singh	PROPN
globalce-210	36	16	,	,	PUNCT
globalce-210	36	17	chauhan	chauhan	PROPN
globalce-210	36	18	:	:	PUNCT
globalce-210	36	19	artificial	artificial	ADJ
globalce-210	36	20	intelligence	intelligence	NOUN
globalce-210	36	21	-	-	PUNCT
globalce-210	36	22	driven	drive	VERB
globalce-210	36	23	insights	insight	NOUN
globalce-210	36	24	for	for	ADP
globalce-210	36	25	regulatory	regulatory	ADJ
globalce-210	36	26	intelligence	intelligence	NOUN
globalce-210	36	27	in	in	ADP
globalce-210	36	28	medical	medical	ADJ
globalce-210	36	29	devices	device	NOUN
globalce-210	36	30	:	:	PUNCT
globalce-210	36	31	evaluating	evaluate	VERB
globalce-210	36	32	ema	ema	PROPN
globalce-210	36	33	,	,	PUNCT
globalce-210	36	34	fda	fda	PROPN
globalce-210	36	35	,	,	PUNCT
globalce-210	36	36	and	and	CCONJ
globalce-210	36	37	cdsco	cdsco	NOUN
globalce-210	36	38	frameworks	framework	NOUN
globalce-210	36	39	enhanced	enhance	VERB
globalce-210	36	40	diagnostics	diagnostic	NOUN
globalce-210	36	41	:	:	PUNCT
globalce-210	36	42	ai	ai	ADJ
globalce-210	36	43	-	-	PUNCT
globalce-210	36	44	powered	power	VERB
globalce-210	36	45	diagnostics	diagnostic	NOUN
globalce-210	36	46	involve	involve	VERB
globalce-210	36	47	analyzing	analyze	VERB
globalce-210	36	48	multiple	multiple	ADJ
globalce-210	36	49	medical	medical	ADJ
globalce-210	36	50	data	datum	NOUN
globalce-210	36	51	sources	source	NOUN
globalce-210	36	52	to	to	PART
globalce-210	36	53	improve	improve	VERB
globalce-210	36	54	early	early	ADJ
globalce-210	36	55	and	and	CCONJ
globalce-210	36	56	accurate	accurate	ADJ
globalce-210	36	57	diagnosis	diagnosis	NOUN
globalce-210	36	58	of	of	ADP
globalce-210	36	59	illnesses	illness	NOUN
globalce-210	36	60	.	.	PUNCT
globalce-210	37	1	this	this	PRON
globalce-210	37	2	includes	include	VERB
globalce-210	37	3	mining	mining	NOUN
globalce-210	37	4	electronic	electronic	ADJ
globalce-210	37	5	health	health	NOUN
globalce-210	37	6	records	record	NOUN
globalce-210	37	7	(	(	PUNCT
globalce-210	37	8	ehrs	ehrs	PROPN
globalce-210	37	9	)	)	PUNCT
globalce-210	37	10	,	,	PUNCT
globalce-210	37	11	automated	automate	VERB
globalce-210	37	12	laboratory	laboratory	NOUN
globalce-210	37	13	report	report	NOUN
globalce-210	37	14	analysis	analysis	NOUN
globalce-210	37	15	,	,	PUNCT
globalce-210	37	16	and	and	CCONJ
globalce-210	37	17	medical	medical	ADJ
globalce-210	37	18	image	image	NOUN
globalce-210	37	19	interpretation	interpretation	NOUN
globalce-210	37	20	(	(	PUNCT
globalce-210	37	21	e.g.	e.g.	ADV
globalce-210	37	22	,	,	PUNCT
globalce-210	37	23	radiology	radiology	NOUN
globalce-210	37	24	,	,	PUNCT
globalce-210	37	25	pathology	pathology	NOUN
globalce-210	37	26	,	,	PUNCT
globalce-210	37	27	etc	etc	X
globalce-210	37	28	.	.	X
globalce-210	37	29	)	)	PUNCT
globalce-210	37	30	.	.	PUNCT
globalce-210	38	1	performance	performance	NOUN
globalce-210	38	2	evaluation	evaluation	NOUN
globalce-210	38	3	:	:	PUNCT
globalce-210	38	4	ai	ai	AUX
globalce-210	38	5	devices	device	NOUN
globalce-210	38	6	can	can	AUX
globalce-210	38	7	be	be	AUX
globalce-210	38	8	helpful	helpful	ADJ
globalce-210	38	9	in	in	ADP
globalce-210	38	10	the	the	DET
globalce-210	38	11	performance	performance	NOUN
globalce-210	38	12	evaluation	evaluation	NOUN
globalce-210	38	13	process	process	NOUN
globalce-210	38	14	by	by	ADP
globalce-210	38	15	increasing	increase	VERB
globalce-210	38	16	efficiency	efficiency	NOUN
globalce-210	38	17	,	,	PUNCT
globalce-210	38	18	improving	improve	VERB
globalce-210	38	19	patient	patient	ADJ
globalce-210	38	20	outcomes	outcome	NOUN
globalce-210	38	21	,	,	PUNCT
globalce-210	38	22	and	and	CCONJ
globalce-210	38	23	simplifying	simplify	VERB
globalce-210	38	24	data	datum	NOUN
globalce-210	38	25	collection	collection	NOUN
globalce-210	38	26	.	.	PUNCT
globalce-210	39	1	this	this	PRON
globalce-210	39	2	includes	include	VERB
globalce-210	39	3	the	the	DET
globalce-210	39	4	use	use	NOUN
globalce-210	39	5	of	of	ADP
globalce-210	39	6	ai	ai	VERB
globalce-210	39	7	in	in	ADP
globalce-210	39	8	post	post	ADJ
globalce-210	39	9	-	-	ADJ
globalce-210	39	10	market	market	ADJ
globalce-210	39	11	surveillance	surveillance	NOUN
globalce-210	39	12	and	and	CCONJ
globalce-210	39	13	real	real	ADJ
globalce-210	39	14	-	-	PUNCT
globalce-210	39	15	world	world	NOUN
globalce-210	39	16	performance	performance	NOUN
globalce-210	39	17	monitoring	monitoring	NOUN
globalce-210	39	18	to	to	PART
globalce-210	39	19	ensure	ensure	VERB
globalce-210	39	20	the	the	DET
globalce-210	39	21	ongoing	ongoing	ADJ
globalce-210	39	22	safety	safety	NOUN
globalce-210	39	23	and	and	CCONJ
globalce-210	39	24	efficacy	efficacy	NOUN
globalce-210	39	25	of	of	ADP
globalce-210	39	26	medical	medical	ADJ
globalce-210	39	27	devices.6	devices.6	PROPN
globalce-210	39	28	predictive	predictive	ADJ
globalce-210	39	29	analytics	analytic	NOUN
globalce-210	39	30	for	for	ADP
globalce-210	39	31	monitoring	monitor	VERB
globalce-210	39	32	:	:	PUNCT
globalce-210	39	33	ai	ai	VERB
globalce-210	39	34	can	can	AUX
globalce-210	39	35	be	be	AUX
globalce-210	39	36	used	use	VERB
globalce-210	39	37	in	in	ADP
globalce-210	39	38	wearable	wearable	ADJ
globalce-210	39	39	devices	device	NOUN
globalce-210	39	40	to	to	PART
globalce-210	39	41	monitor	monitor	VERB
globalce-210	39	42	patient	patient	ADJ
globalce-210	39	43	vitals	vital	NOUN
globalce-210	39	44	and	and	CCONJ
globalce-210	39	45	provide	provide	VERB
globalce-210	39	46	predictive	predictive	ADJ
globalce-210	39	47	insights	insight	NOUN
globalce-210	39	48	on	on	ADP
globalce-210	39	49	conditions	condition	NOUN
globalce-210	39	50	such	such	ADJ
globalce-210	39	51	as	as	ADP
globalce-210	39	52	heart	heart	NOUN
globalce-210	39	53	failure	failure	NOUN
globalce-210	39	54	and	and	CCONJ
globalce-210	39	55	glucose	glucose	NOUN
globalce-210	39	56	levels	level	NOUN
globalce-210	39	57	.	.	PUNCT
globalce-210	40	1	regulatory	regulatory	ADJ
globalce-210	40	2	compliance	compliance	NOUN
globalce-210	40	3	and	and	CCONJ
globalce-210	40	4	clinical	clinical	ADJ
globalce-210	40	5	trials	trial	NOUN
globalce-210	40	6	:	:	PUNCT
globalce-210	40	7	ai	ai	VERB
globalce-210	40	8	can	can	AUX
globalce-210	40	9	automate	automate	VERB
globalce-210	40	10	data	data	NOUN
globalce-210	40	11	generation	generation	NOUN
globalce-210	40	12	,	,	PUNCT
globalce-210	40	13	validation	validation	NOUN
globalce-210	40	14	,	,	PUNCT
globalce-210	40	15	and	and	CCONJ
globalce-210	40	16	metadata	metadata	VERB
globalce-210	40	17	analysis	analysis	NOUN
globalce-210	40	18	for	for	ADP
globalce-210	40	19	regulatory	regulatory	ADJ
globalce-210	40	20	submissions	submission	NOUN
globalce-210	40	21	,	,	PUNCT
globalce-210	40	22	enhancing	enhance	VERB
globalce-210	40	23	clinical	clinical	ADJ
globalce-210	40	24	trials	trial	NOUN
globalce-210	40	25	by	by	ADP
globalce-210	40	26	predicting	predict	VERB
globalce-210	40	27	outcomes	outcome	NOUN
globalce-210	40	28	,	,	PUNCT
globalce-210	40	29	optimizing	optimize	VERB
globalce-210	40	30	patient	patient	ADJ
globalce-210	40	31	recruitment	recruitment	NOUN
globalce-210	40	32	,	,	PUNCT
globalce-210	40	33	and	and	CCONJ
globalce-210	40	34	ensuring	ensure	VERB
globalce-210	40	35	compliance	compliance	NOUN
globalce-210	40	36	with	with	ADP
globalce-210	40	37	global	global	ADJ
globalce-210	40	38	regulatory	regulatory	ADJ
globalce-210	40	39	standards	standard	NOUN
globalce-210	40	40	.	.	PUNCT
globalce-210	41	1	ai	ai	VERB
globalce-210	41	2	for	for	ADP
globalce-210	41	3	diagnostics	diagnostic	NOUN
globalce-210	41	4	:	:	PUNCT
globalce-210	41	5	ml	ml	X
globalce-210	41	6	models	model	NOUN
globalce-210	41	7	in	in	ADP
globalce-210	41	8	diagnostic	diagnostic	ADJ
globalce-210	41	9	devices	device	NOUN
globalce-210	41	10	can	can	AUX
globalce-210	41	11	aid	aid	VERB
globalce-210	41	12	in	in	ADP
globalce-210	41	13	the	the	DET
globalce-210	41	14	automatic	automatic	ADJ
globalce-210	41	15	interpretation	interpretation	NOUN
globalce-210	41	16	of	of	ADP
globalce-210	41	17	test	test	NOUN
globalce-210	41	18	results	result	NOUN
globalce-210	41	19	,	,	PUNCT
globalce-210	41	20	such	such	ADJ
globalce-210	41	21	as	as	ADP
globalce-210	41	22	ecg	ecg	PROPN
globalce-210	41	23	and	and	CCONJ
globalce-210	41	24	blood	blood	NOUN
globalce-210	41	25	tests	test	NOUN
globalce-210	41	26	.	.	PUNCT
globalce-210	42	1	natural	natural	ADJ
globalce-210	42	2	language	language	NOUN
globalce-210	42	3	processing	processing	NOUN
globalce-210	42	4	(	(	PUNCT
globalce-210	42	5	nlp	nlp	NOUN
globalce-210	42	6	)	)	PUNCT
globalce-210	42	7	for	for	ADP
globalce-210	42	8	documentation	documentation	NOUN
globalce-210	42	9	:	:	PUNCT
globalce-210	42	10	ai	ai	VERB
globalce-210	42	11	can	can	AUX
globalce-210	42	12	automate	automate	VERB
globalce-210	42	13	and	and	CCONJ
globalce-210	42	14	streamline	streamline	VERB
globalce-210	42	15	clinical	clinical	ADJ
globalce-210	42	16	documentation	documentation	NOUN
globalce-210	42	17	,	,	PUNCT
globalce-210	42	18	making	make	VERB
globalce-210	42	19	it	it	PRON
globalce-210	42	20	easier	easy	ADJ
globalce-210	42	21	to	to	PART
globalce-210	42	22	comply	comply	VERB
globalce-210	42	23	with	with	ADP
globalce-210	42	24	medical	medical	ADJ
globalce-210	42	25	regulations	regulation	NOUN
globalce-210	42	26	and	and	CCONJ
globalce-210	42	27	ensure	ensure	VERB
globalce-210	42	28	accurate	accurate	ADJ
globalce-210	42	29	patient	patient	NOUN
globalce-210	42	30	records	record	NOUN
globalce-210	42	31	.	.	PUNCT
globalce-210	43	1	robotic	robotic	ADJ
globalce-210	43	2	surgery	surgery	NOUN
globalce-210	43	3	:	:	PUNCT
globalce-210	43	4	ml	ml	ADP
globalce-210	43	5	algorithms	algorithm	NOUN
globalce-210	43	6	can	can	AUX
globalce-210	43	7	assist	assist	VERB
globalce-210	43	8	surgeons	surgeon	NOUN
globalce-210	43	9	with	with	ADP
globalce-210	43	10	precision	precision	NOUN
globalce-210	43	11	during	during	ADP
globalce-210	43	12	operations	operation	NOUN
globalce-210	43	13	.	.	PUNCT
globalce-210	44	1	ai	ai	VERB
globalce-210	44	2	in	in	ADP
globalce-210	44	3	software	software	NOUN
globalce-210	44	4	as	as	ADP
globalce-210	44	5	a	a	DET
globalce-210	44	6	medical	medical	ADJ
globalce-210	44	7	device	device	NOUN
globalce-210	44	8	(	(	PUNCT
globalce-210	44	9	samd	samd	ADJ
globalce-210	44	10	):	):	PUNCT
globalce-210	44	11	ai	ai	VERB
globalce-210	44	12	is	be	AUX
globalce-210	44	13	being	be	AUX
globalce-210	44	14	integrated	integrate	VERB
globalce-210	44	15	increasingly	increasingly	ADV
globalce-210	44	16	into	into	ADP
globalce-210	44	17	samd	samd	NOUN
globalce-210	44	18	to	to	PART
globalce-210	44	19	enhance	enhance	VERB
globalce-210	44	20	functionality	functionality	NOUN
globalce-210	44	21	and	and	CCONJ
globalce-210	44	22	performance	performance	NOUN
globalce-210	44	23	.	.	PUNCT
globalce-210	45	1	importance	importance	NOUN
globalce-210	45	2	of	of	ADP
globalce-210	45	3	regulatory	regulatory	ADJ
globalce-210	45	4	intelligence	intelligence	NOUN
globalce-210	45	5	and	and	CCONJ
globalce-210	45	6	compliance	compliance	NOUN
globalce-210	45	7	monitoring	monitor	VERB
globalce-210	45	8	regulatory	regulatory	ADJ
globalce-210	45	9	intelligence	intelligence	NOUN
globalce-210	45	10	is	be	AUX
globalce-210	45	11	essential	essential	ADJ
globalce-210	45	12	for	for	ADP
globalce-210	45	13	compliance	compliance	NOUN
globalce-210	45	14	monitoring	monitoring	NOUN
globalce-210	45	15	,	,	PUNCT
globalce-210	45	16	helping	help	VERB
globalce-210	45	17	companies	company	NOUN
globalce-210	45	18	to	to	PART
globalce-210	45	19	keep	keep	VERB
globalce-210	45	20	updated	update	VERB
globalce-210	45	21	about	about	ADP
globalce-210	45	22	changing	change	VERB
globalce-210	45	23	regulations	regulation	NOUN
globalce-210	45	24	.	.	PUNCT
globalce-210	46	1	it	it	PRON
globalce-210	46	2	ensures	ensure	VERB
globalce-210	46	3	that	that	SCONJ
globalce-210	46	4	the	the	DET
globalce-210	46	5	company	company	NOUN
globalce-210	46	6	remains	remain	VERB
globalce-210	46	7	in	in	ADP
globalce-210	46	8	accordance	accordance	NOUN
globalce-210	46	9	with	with	ADP
globalce-210	46	10	all	all	DET
globalce-210	46	11	laws	law	NOUN
globalce-210	46	12	and	and	CCONJ
globalce-210	46	13	requirements	requirement	NOUN
globalce-210	46	14	.	.	PUNCT
globalce-210	47	1	regulatory	regulatory	ADJ
globalce-210	47	2	intelligence	intelligence	NOUN
globalce-210	47	3	empowers	empower	VERB
globalce-210	47	4	businesses	business	NOUN
globalce-210	47	5	in	in	ADP
globalce-210	47	6	anticipating	anticipate	VERB
globalce-210	47	7	and	and	CCONJ
globalce-210	47	8	dealing	deal	VERB
globalce-210	47	9	with	with	ADP
globalce-210	47	10	global	global	ADJ
globalce-210	47	11	changes	change	NOUN
globalce-210	47	12	in	in	ADP
globalce-210	47	13	regulations	regulation	NOUN
globalce-210	47	14	,	,	PUNCT
globalce-210	47	15	without	without	ADP
globalce-210	47	16	having	have	VERB
globalce-210	47	17	to	to	PART
globalce-210	47	18	monitor	monitor	VERB
globalce-210	47	19	manually	manually	ADV
globalce-210	47	20	different	different	ADJ
globalce-210	47	21	sources	source	NOUN
globalce-210	47	22	of	of	ADP
globalce-210	47	23	regulatory	regulatory	ADJ
globalce-210	47	24	data	datum	NOUN
globalce-210	47	25	.	.	PUNCT
globalce-210	48	1	a	a	DET
globalce-210	48	2	proactive	proactive	ADJ
globalce-210	48	3	approach	approach	NOUN
globalce-210	48	4	ensures	ensure	VERB
globalce-210	48	5	organizations	organization	NOUN
globalce-210	48	6	respond	respond	VERB
globalce-210	48	7	faster	fast	ADV
globalce-210	48	8	to	to	PART
globalce-210	48	9	make	make	VERB
globalce-210	48	10	the	the	DET
globalce-210	48	11	changes	change	NOUN
globalce-210	48	12	they	they	PRON
globalce-210	48	13	need	need	VERB
globalce-210	48	14	,	,	PUNCT
globalce-210	48	15	mitigating	mitigate	VERB
globalce-210	48	16	risk	risk	NOUN
globalce-210	48	17	and	and	CCONJ
globalce-210	48	18	reducing	reduce	VERB
globalce-210	48	19	costs	cost	NOUN
globalce-210	48	20	.	.	PUNCT
globalce-210	49	1	for	for	ADP
globalce-210	49	2	example	example	NOUN
globalce-210	49	3	,	,	PUNCT
globalce-210	49	4	regulatory	regulatory	ADJ
globalce-210	49	5	intelligence	intelligence	NOUN
globalce-210	49	6	platforms	platform	NOUN
globalce-210	49	7	have	have	VERB
globalce-210	49	8	tools	tool	NOUN
globalce-210	49	9	for	for	ADP
globalce-210	49	10	tracking	track	VERB
globalce-210	49	11	changes	change	NOUN
globalce-210	49	12	in	in	ADP
globalce-210	49	13	the	the	DET
globalce-210	49	14	rules	rule	NOUN
globalce-210	49	15	and	and	CCONJ
globalce-210	49	16	analyzing	analyze	VERB
globalce-210	49	17	their	their	PRON
globalce-210	49	18	impact	impact	NOUN
globalce-210	49	19	to	to	PART
globalce-210	49	20	discover	discover	VERB
globalce-210	49	21	which	which	DET
globalce-210	49	22	obligations	obligation	NOUN
globalce-210	49	23	might	might	AUX
globalce-210	49	24	stem	stem	VERB
globalce-210	49	25	from	from	ADP
globalce-210	49	26	a	a	DET
globalce-210	49	27	change	change	NOUN
globalce-210	49	28	of	of	ADP
globalce-210	49	29	laws	law	NOUN
globalce-210	49	30	that	that	PRON
globalce-210	49	31	may	may	AUX
globalce-210	49	32	apply	apply	VERB
globalce-210	49	33	specifically	specifically	ADV
globalce-210	49	34	depending	depend	VERB
globalce-210	49	35	on	on	ADP
globalce-210	49	36	what	what	PRON
globalce-210	49	37	is	be	AUX
globalce-210	49	38	being	be	AUX
globalce-210	49	39	done	do	VERB
globalce-210	49	40	by	by	ADP
globalce-210	49	41	you.7	you.7	PROPN
globalce-210	49	42	these	these	DET
globalce-210	49	43	tools	tool	NOUN
globalce-210	49	44	ensure	ensure	VERB
globalce-210	49	45	the	the	DET
globalce-210	49	46	regulatory	regulatory	ADJ
globalce-210	49	47	updates	update	NOUN
globalce-210	49	48	and	and	CCONJ
globalce-210	49	49	reports	report	NOUN
globalce-210	49	50	generated	generate	VERB
globalce-210	49	51	on	on	ADP
globalce-210	49	52	the	the	DET
globalce-210	49	53	platform	platform	NOUN
globalce-210	49	54	itself	itself	PRON
globalce-210	49	55	,	,	PUNCT
globalce-210	49	56	making	make	VERB
globalce-210	49	57	it	it	PRON
globalce-210	49	58	more	more	ADV
globalce-210	49	59	efficient	efficient	ADJ
globalce-210	49	60	for	for	ADP
globalce-210	49	61	operations	operation	NOUN
globalce-210	49	62	at	at	ADP
globalce-210	49	63	lower	low	ADJ
globalce-210	49	64	cost	cost	NOUN
globalce-210	49	65	.	.	PUNCT
globalce-210	50	1	for	for	ADP
globalce-210	50	2	instance	instance	NOUN
globalce-210	50	3	,	,	PUNCT
globalce-210	50	4	the	the	DET
globalce-210	50	5	use	use	NOUN
globalce-210	50	6	of	of	ADP
globalce-210	50	7	ai	ai	NOUN
globalce-210	50	8	in	in	ADP
globalce-210	50	9	regulatory	regulatory	ADJ
globalce-210	50	10	intelligence	intelligence	NOUN
globalce-210	50	11	is	be	AUX
globalce-210	50	12	expected	expect	VERB
globalce-210	50	13	to	to	PART
globalce-210	50	14	automate	automate	VERB
globalce-210	50	15	monitoring	monitoring	NOUN
globalce-210	50	16	and	and	CCONJ
globalce-210	50	17	dissemination	dissemination	NOUN
globalce-210	50	18	in	in	ADP
globalce-210	50	19	the	the	DET
globalce-210	50	20	future	future	NOUN
globalce-210	50	21	,	,	PUNCT
globalce-210	50	22	freeing	free	VERB
globalce-210	50	23	up	up	ADP
globalce-210	50	24	regulatory	regulatory	ADJ
globalce-210	50	25	experts	expert	NOUN
globalce-210	50	26	to	to	PART
globalce-210	50	27	concentrate	concentrate	VERB
globalce-210	50	28	on	on	ADP
globalce-210	50	29	high	high	ADJ
globalce-210	50	30	-	-	PUNCT
globalce-210	50	31	value	value	NOUN
globalce-210	50	32	tasks	task	NOUN
globalce-210	50	33	and	and	CCONJ
globalce-210	50	34	decision	decision	NOUN
globalce-210	50	35	-	-	PUNCT
globalce-210	50	36	making.8	making.8	PRON
globalce-210	50	37	regulatory	regulatory	ADJ
globalce-210	50	38	information	information	NOUN
globalce-210	50	39	tools	tool	NOUN
globalce-210	50	40	for	for	ADP
globalce-210	50	41	monitoring	monitor	VERB
globalce-210	50	42	consist	consist	NOUN
globalce-210	50	43	of	of	ADP
globalce-210	50	44	regulatory	regulatory	ADJ
globalce-210	50	45	agencies	agency	NOUN
globalce-210	50	46	,	,	PUNCT
globalce-210	50	47	website	website	NOUN
globalce-210	50	48	monitoring	monitoring	NOUN
globalce-210	50	49	tools	tool	NOUN
globalce-210	50	50	,	,	PUNCT
globalce-210	50	51	news	news	NOUN
globalce-210	50	52	organizations	organization	NOUN
globalce-210	50	53	,	,	PUNCT
globalce-210	50	54	and	and	CCONJ
globalce-210	50	55	subscription	subscription	NOUN
globalce-210	50	56	-	-	PUNCT
globalce-210	50	57	based	base	VERB
globalce-210	50	58	services	service	NOUN
globalce-210	50	59	regulatory	regulatory	ADJ
globalce-210	50	60	intelligence	intelligence	NOUN
globalce-210	50	61	for	for	ADP
globalce-210	50	62	regulatory	regulatory	ADJ
globalce-210	50	63	strategies	strategy	NOUN
globalce-210	50	64	and	and	CCONJ
globalce-210	50	65	operations	operation	NOUN
globalce-210	50	66	,	,	PUNCT
globalce-210	50	67	product	product	NOUN
globalce-210	50	68	due	due	ADJ
globalce-210	50	69	diligence	diligence	NOUN
globalce-210	50	70	(	(	PUNCT
globalce-210	50	71	preor	preor	NOUN
globalce-210	50	72	post	post	NOUN
globalce-210	50	73	-	-	NOUN
globalce-210	50	74	deal	deal	NOUN
globalce-210	50	75	)	)	PUNCT
globalce-210	50	76	,	,	PUNCT
globalce-210	50	77	target	target	NOUN
globalce-210	50	78	products	product	NOUN
globalce-210	50	79	identification	identification	NOUN
globalce-210	50	80	,	,	PUNCT
globalce-210	50	81	and	and	CCONJ
globalce-210	50	82	clinical	clinical	ADJ
globalce-210	50	83	development	development	NOUN
globalce-210	50	84	to	to	ADP
globalce-210	50	85	regulatory	regulatory	ADJ
globalce-210	50	86	submissions	submission	NOUN
globalce-210	50	87	.	.	PUNCT
globalce-210	51	1	this	this	DET
globalce-210	51	2	capability	capability	NOUN
globalce-210	51	3	helps	help	VERB
globalce-210	51	4	organizations	organization	NOUN
globalce-210	51	5	stay	stay	VERB
globalce-210	51	6	current	current	ADJ
globalce-210	51	7	with	with	ADP
globalce-210	51	8	applicable	applicable	ADJ
globalce-210	51	9	regulations	regulation	NOUN
globalce-210	51	10	,	,	PUNCT
globalce-210	51	11	understand	understand	VERB
globalce-210	51	12	the	the	DET
globalce-210	51	13	implications	implication	NOUN
globalce-210	51	14	,	,	PUNCT
globalce-210	51	15	and	and	CCONJ
globalce-210	51	16	create	create	VERB
globalce-210	51	17	an	an	DET
globalce-210	51	18	intelligence	intelligence	NOUN
globalce-210	51	19	report	report	NOUN
globalce-210	51	20	that	that	PRON
globalce-210	51	21	can	can	AUX
globalce-210	51	22	be	be	AUX
globalce-210	51	23	used	use	VERB
globalce-210	51	24	to	to	PART
globalce-210	51	25	remain	remain	VERB
globalce-210	51	26	compliant	compliant	ADJ
globalce-210	51	27	while	while	SCONJ
globalce-210	51	28	reducing	reduce	VERB
globalce-210	51	29	resource	resource	NOUN
globalce-210	51	30	overhead.9	overhead.9	PROPN
globalce-210	51	31	need	need	VERB
globalce-210	51	32	for	for	ADP
globalce-210	51	33	effective	effective	ADJ
globalce-210	51	34	regulatory	regulatory	ADJ
globalce-210	51	35	frameworks	framework	NOUN
globalce-210	51	36	to	to	PART
globalce-210	51	37	keep	keep	VERB
globalce-210	51	38	pace	pace	NOUN
globalce-210	51	39	with	with	ADP
globalce-210	51	40	ai	ai	ADJ
globalce-210	51	41	innovations	innovation	NOUN
globalce-210	51	42	for	for	ADP
globalce-210	51	43	medical	medical	ADJ
globalce-210	51	44	devices	device	NOUN
globalce-210	51	45	the	the	DET
globalce-210	51	46	current	current	ADJ
globalce-210	51	47	regulatory	regulatory	ADJ
globalce-210	51	48	framework	framework	NOUN
globalce-210	51	49	for	for	ADP
globalce-210	51	50	ai	ai	ADJ
globalce-210	51	51	-	-	PUNCT
globalce-210	51	52	enabled	enable	VERB
globalce-210	51	53	medical	medical	ADJ
globalce-210	51	54	devices	device	NOUN
globalce-210	51	55	is	be	AUX
globalce-210	51	56	characterized	characterize	VERB
globalce-210	51	57	by	by	ADP
globalce-210	51	58	a	a	DET
globalce-210	51	59	wide	wide	ADJ
globalce-210	51	60	void	void	NOUN
globalce-210	51	61	of	of	ADP
globalce-210	51	62	strict	strict	ADJ
globalce-210	51	63	laws	law	NOUN
globalce-210	51	64	and	and	CCONJ
globalce-210	51	65	guidelines	guideline	NOUN
globalce-210	51	66	.	.	PUNCT
globalce-210	52	1	the	the	DET
globalce-210	52	2	fda	fda	PROPN
globalce-210	52	3	(	(	PUNCT
globalce-210	52	4	united	united	PROPN
globalce-210	52	5	states	states	PROPN
globalce-210	52	6	)	)	PUNCT
globalce-210	52	7	,	,	PUNCT
globalce-210	52	8	the	the	DET
globalce-210	52	9	medicines	medicine	NOUN
globalce-210	52	10	and	and	CCONJ
globalce-210	52	11	healthcare	healthcare	NOUN
globalce-210	52	12	products	product	NOUN
globalce-210	52	13	regulatory	regulatory	ADJ
globalce-210	52	14	agency	agency	NOUN
globalce-210	52	15	(	(	PUNCT
globalce-210	52	16	mhra	mhra	NOUN
globalce-210	52	17	,	,	PUNCT
globalce-210	52	18	uk	uk	PROPN
globalce-210	52	19	)	)	PUNCT
globalce-210	52	20	,	,	PUNCT
globalce-210	52	21	and	and	CCONJ
globalce-210	52	22	the	the	DET
globalce-210	52	23	health	health	NOUN
globalce-210	52	24	canada	canada	PROPN
globalce-210	52	25	have	have	AUX
globalce-210	52	26	published	publish	VERB
globalce-210	52	27	preliminary	preliminary	ADJ
globalce-210	52	28	thoughts	thought	NOUN
globalce-210	52	29	;	;	PUNCT
globalce-210	52	30	however	however	ADV
globalce-210	52	31	,	,	PUNCT
globalce-210	52	32	regulations	regulation	NOUN
globalce-210	52	33	by	by	ADP
globalce-210	52	34	law	law	NOUN
globalce-210	52	35	are	be	AUX
globalce-210	52	36	only	only	ADV
globalce-210	52	37	enforceable	enforceable	ADJ
globalce-210	52	38	when	when	SCONJ
globalce-210	52	39	issued	issue	VERB
globalce-210	52	40	.	.	PUNCT
globalce-210	53	1	only	only	ADV
globalce-210	53	2	saudi	saudi	PROPN
globalce-210	53	3	arabia	arabia	PROPN
globalce-210	53	4	has	have	AUX
globalce-210	53	5	implemented	implement	VERB
globalce-210	53	6	proscriptive	proscriptive	ADJ
globalce-210	53	7	guidance	guidance	NOUN
globalce-210	53	8	so	so	ADV
globalce-210	53	9	far	far	ADV
globalce-210	53	10	.	.	PUNCT
globalce-210	54	1	this	this	DET
globalce-210	54	2	ambiguity	ambiguity	NOUN
globalce-210	54	3	obliges	oblige	VERB
globalce-210	54	4	manufacturers	manufacturer	NOUN
globalce-210	54	5	to	to	PART
globalce-210	54	6	employ	employ	VERB
globalce-210	54	7	regulations	regulation	NOUN
globalce-210	54	8	not	not	PART
globalce-210	54	9	modernized	modernize	VERB
globalce-210	54	10	for	for	ADP
globalce-210	54	11	the	the	DET
globalce-210	54	12	new	new	ADJ
globalce-210	54	13	and	and	CCONJ
globalce-210	54	14	revised	revise	VERB
globalce-210	54	15	short	short	ADJ
globalce-210	54	16	-	-	PUNCT
globalce-210	54	17	cycle	cycle	NOUN
globalce-210	54	18	drugs	drug	NOUN
globalce-210	54	19	,	,	PUNCT
globalce-210	54	20	serving	serve	VERB
globalce-210	54	21	as	as	ADP
globalce-210	54	22	roadblocks	roadblock	NOUN
globalce-210	54	23	toward	toward	ADP
globalce-210	54	24	algorithmic	algorithmic	ADJ
globalce-210	54	25	adaptability	adaptability	NOUN
globalce-210	54	26	along	along	ADP
globalce-210	54	27	with	with	ADP
globalce-210	54	28	dynamic	dynamic	ADJ
globalce-210	54	29	data	data	NOUN
globalce-210	54	30	-	-	PUNCT
globalce-210	54	31	driven	drive	VERB
globalce-210	54	32	updates	update	NOUN
globalce-210	54	33	by	by	ADP
globalce-210	54	34	treating	treat	VERB
globalce-210	54	35	newly	newly	ADV
globalce-210	54	36	acquired	acquire	VERB
globalce-210	54	37	information	information	NOUN
globalce-210	54	38	without	without	ADP
globalce-210	54	39	constraints.10	constraints.10	PROPN
globalce-210	54	40	gaur	gaur	NOUN
globalce-210	54	41	,	,	PUNCT
globalce-210	54	42	akram	akram	PROPN
globalce-210	54	43	,	,	PUNCT
globalce-210	54	44	singh	singh	PROPN
globalce-210	54	45	,	,	PUNCT
globalce-210	54	46	chauhan	chauhan	PROPN
globalce-210	54	47	:	:	PUNCT
globalce-210	54	48	artificial	artificial	ADJ
globalce-210	54	49	intelligence	intelligence	NOUN
globalce-210	54	50	-	-	PUNCT
globalce-210	54	51	driven	drive	VERB
globalce-210	54	52	insights	insight	NOUN
globalce-210	54	53	for	for	ADP
globalce-210	54	54	regulatory	regulatory	ADJ
globalce-210	54	55	intelligence	intelligence	NOUN
globalce-210	54	56	in	in	ADP
globalce-210	54	57	medical	medical	ADJ
globalce-210	54	58	devices	device	NOUN
globalce-210	54	59	:	:	PUNCT
globalce-210	54	60	evaluating	evaluate	VERB
globalce-210	54	61	ema	ema	PROPN
globalce-210	54	62	,	,	PUNCT
globalce-210	54	63	fda	fda	PROPN
globalce-210	54	64	,	,	PUNCT
globalce-210	54	65	and	and	CCONJ
globalce-210	54	66	cdsco	cdsco	PROPN
globalce-210	54	67	frameworks	framework	VERB
globalce-210	54	68	j	j	PROPN
globalce-210	54	69	global	global	ADJ
globalce-210	54	70	clinical	clinical	ADJ
globalce-210	54	71	engineering	engineering	NOUN
globalce-210	54	72	vol.7	vol.7	PROPN
globalce-210	54	73	issue	issue	NOUN
globalce-210	54	74	2	2	NUM
globalce-210	54	75	:	:	PUNCT
globalce-210	54	76	2025	2025	NUM
globalce-210	54	77	14	14	NUM
globalce-210	54	78	essential	essential	ADJ
globalce-210	54	79	when	when	SCONJ
globalce-210	54	80	utilizing	utilize	VERB
globalce-210	54	81	ce	ce	NOUN
globalce-210	54	82	-	-	ADJ
globalce-210	54	83	certified	certify	VERB
globalce-210	54	84	devices	device	NOUN
globalce-210	54	85	in	in	ADP
globalce-210	54	86	a	a	DET
globalce-210	54	87	clinical	clinical	ADJ
globalce-210	54	88	trial	trial	NOUN
globalce-210	54	89	to	to	PART
globalce-210	54	90	safeguard	safeguard	VERB
globalce-210	54	91	the	the	DET
globalce-210	54	92	rights	right	NOUN
globalce-210	54	93	,	,	PUNCT
globalce-210	54	94	safety	safety	NOUN
globalce-210	54	95	,	,	PUNCT
globalce-210	54	96	and	and	CCONJ
globalce-210	54	97	well	well	ADV
globalce-210	54	98	-	-	PUNCT
globalce-210	54	99	being	being	NOUN
globalce-210	54	100	of	of	ADP
globalce-210	54	101	participants	participant	NOUN
globalce-210	54	102	as	as	ADV
globalce-210	54	103	well	well	ADV
globalce-210	54	104	as	as	ADP
globalce-210	54	105	the	the	DET
globalce-210	54	106	integrity	integrity	NOUN
globalce-210	54	107	,	,	PUNCT
globalce-210	54	108	and	and	CCONJ
globalce-210	54	109	applicability	applicability	NOUN
globalce-210	54	110	of	of	ADP
globalce-210	54	111	evaluation	evaluation	NOUN
globalce-210	54	112	data	datum	NOUN
globalce-210	54	113	.	.	PUNCT
globalce-210	55	1	it	it	PRON
globalce-210	55	2	is	be	AUX
globalce-210	55	3	clear	clear	ADJ
globalce-210	55	4	from	from	ADP
globalce-210	55	5	the	the	DET
globalce-210	55	6	reflection	reflection	NOUN
globalce-210	55	7	paper	paper	NOUN
globalce-210	55	8	that	that	PRON
globalce-210	55	9	ema	ema	PROPN
globalce-210	55	10	scrutinizes	scrutinize	VERB
globalce-210	55	11	whether	whether	SCONJ
globalce-210	55	12	the	the	DET
globalce-210	55	13	characteristics	characteristic	NOUN
globalce-210	55	14	of	of	ADP
globalce-210	55	15	medical	medical	ADJ
globalce-210	55	16	devices	device	NOUN
globalce-210	55	17	are	be	AUX
globalce-210	55	18	suitable	suitable	ADJ
globalce-210	55	19	for	for	ADP
globalce-210	55	20	generating	generate	VERB
globalce-210	55	21	evidence	evidence	NOUN
globalce-210	55	22	needed	need	VERB
globalce-210	55	23	for	for	ADP
globalce-210	55	24	marketing	marketing	NOUN
globalce-210	55	25	authorization	authorization	NOUN
globalce-210	55	26	application	application	NOUN
globalce-210	55	27	,	,	PUNCT
globalce-210	55	28	or	or	CCONJ
globalce-210	55	29	whether	whether	SCONJ
globalce-210	55	30	a	a	DET
globalce-210	55	31	device	device	NOUN
globalce-210	55	32	provides	provide	VERB
globalce-210	55	33	recommendations	recommendation	NOUN
globalce-210	55	34	in	in	ADP
globalce-210	55	35	the	the	DET
globalce-210	55	36	summary	summary	NOUN
globalce-210	55	37	of	of	ADP
globalce-210	55	38	product	product	NOUN
globalce-210	55	39	characteristics	characteristic	NOUN
globalce-210	55	40	(	(	PUNCT
globalce-210	55	41	smpc).15	smpc).15	PROPN
globalce-210	55	42	ema	ema	PROPN
globalce-210	55	43	’s	’s	PART
globalce-210	55	44	approach	approach	NOUN
globalce-210	55	45	to	to	ADP
globalce-210	55	46	evaluating	evaluate	VERB
globalce-210	55	47	ai	ai	PROPN
globalce-210	55	48	technologies	technology	NOUN
globalce-210	55	49	in	in	ADP
globalce-210	55	50	medical	medical	ADJ
globalce-210	55	51	device	device	NOUN
globalce-210	55	52	development	development	NOUN
globalce-210	55	53	and	and	CCONJ
globalce-210	55	54	authorization	authorization	NOUN
globalce-210	55	55	the	the	DET
globalce-210	55	56	ema	ema	PROPN
globalce-210	55	57	’s	’s	PART
globalce-210	55	58	strategy	strategy	NOUN
globalce-210	55	59	for	for	ADP
globalce-210	55	60	assessing	assess	VERB
globalce-210	55	61	ai	ai	VERB
globalce-210	55	62	technologies	technology	NOUN
globalce-210	55	63	in	in	ADP
globalce-210	55	64	the	the	DET
globalce-210	55	65	development	development	NOUN
globalce-210	55	66	of	of	ADP
globalce-210	55	67	medical	medical	ADJ
globalce-210	55	68	products	product	NOUN
globalce-210	55	69	is	be	AUX
globalce-210	55	70	as	as	SCONJ
globalce-210	55	71	follows	follow	VERB
globalce-210	55	72	:	:	PUNCT
globalce-210	55	73	the	the	DET
globalce-210	55	74	ema	ema	PROPN
globalce-210	55	75	has	have	AUX
globalce-210	55	76	released	release	VERB
globalce-210	55	77	a	a	DET
globalce-210	55	78	reflection	reflection	NOUN
globalce-210	55	79	paper	paper	NOUN
globalce-210	55	80	that	that	PRON
globalce-210	55	81	focuses	focus	VERB
globalce-210	55	82	on	on	ADP
globalce-210	55	83	promoting	promote	VERB
globalce-210	55	84	the	the	DET
globalce-210	55	85	utilization	utilization	NOUN
globalce-210	55	86	of	of	ADP
globalce-210	55	87	ai	ai	VERB
globalce-210	55	88	throughout	throughout	ADP
globalce-210	55	89	the	the	DET
globalce-210	55	90	lifecycle	lifecycle	NOUN
globalce-210	55	91	of	of	ADP
globalce-210	55	92	medicinal	medicinal	ADJ
globalce-210	55	93	products	product	NOUN
globalce-210	55	94	.	.	PUNCT
globalce-210	56	1	this	this	PRON
globalce-210	56	2	covers	cover	VERB
globalce-210	56	3	medical	medical	ADJ
globalce-210	56	4	devices	device	NOUN
globalce-210	56	5	that	that	PRON
globalce-210	56	6	are	be	AUX
globalce-210	56	7	used	use	VERB
globalce-210	56	8	within	within	ADP
globalce-210	56	9	clinical	clinical	ADJ
globalce-210	56	10	trials	trial	NOUN
globalce-210	56	11	to	to	PART
globalce-210	56	12	provide	provide	VERB
globalce-210	56	13	evidence	evidence	NOUN
globalce-210	56	14	for	for	ADP
globalce-210	56	15	a	a	DET
globalce-210	56	16	marketing	marketing	NOUN
globalce-210	56	17	authorization	authorization	NOUN
globalce-210	56	18	application	application	NOUN
globalce-210	56	19	or	or	CCONJ
globalce-210	56	20	in	in	ADP
globalce-210	56	21	case	case	NOUN
globalce-210	56	22	they	they	PRON
globalce-210	56	23	are	be	AUX
globalce-210	56	24	used	use	VERB
globalce-210	56	25	with	with	ADP
globalce-210	56	26	a	a	DET
globalce-210	56	27	medicinal	medicinal	ADJ
globalce-210	56	28	product.16	product.16	NOUN
globalce-210	56	29	the	the	DET
globalce-210	56	30	ema	ema	PROPN
globalce-210	56	31	assesses	assess	VERB
globalce-210	56	32	such	such	ADJ
globalce-210	56	33	devices	device	NOUN
globalce-210	56	34	to	to	PART
globalce-210	56	35	decide	decide	VERB
globalce-210	56	36	whether	whether	SCONJ
globalce-210	56	37	they	they	PRON
globalce-210	56	38	can	can	AUX
globalce-210	56	39	provide	provide	VERB
globalce-210	56	40	adequate	adequate	ADJ
globalce-210	56	41	evidence	evidence	NOUN
globalce-210	56	42	for	for	ADP
globalce-210	56	43	approval	approval	NOUN
globalce-210	56	44	in	in	ADP
globalce-210	56	45	eu	eu	PROPN
globalce-210	56	46	countries	country	NOUN
globalce-210	56	47	.	.	PUNCT
globalce-210	57	1	these	these	DET
globalce-210	57	2	recommendations	recommendation	NOUN
globalce-210	57	3	include	include	VERB
globalce-210	57	4	information	information	NOUN
globalce-210	57	5	about	about	ADP
globalce-210	57	6	how	how	SCONJ
globalce-210	57	7	to	to	PART
globalce-210	57	8	conduct	conduct	VERB
globalce-210	57	9	ai	ai	PROPN
globalce-210	57	10	research	research	NOUN
globalce-210	57	11	,	,	PUNCT
globalce-210	57	12	which	which	PRON
globalce-210	57	13	needs	need	VERB
globalce-210	57	14	to	to	PART
globalce-210	57	15	be	be	AUX
globalce-210	57	16	updated	update	VERB
globalce-210	57	17	regularly	regularly	ADV
globalce-210	57	18	,	,	PUNCT
globalce-210	57	19	given	give	VERB
globalce-210	57	20	the	the	DET
globalce-210	57	21	advances	advance	NOUN
globalce-210	57	22	in	in	ADP
globalce-210	57	23	the	the	DET
globalce-210	57	24	field	field	NOUN
globalce-210	57	25	and	and	CCONJ
globalce-210	57	26	the	the	DET
globalce-210	57	27	new	new	ADJ
globalce-210	57	28	knowledge	knowledge	NOUN
globalce-210	57	29	generated	generate	VERB
globalce-210	57	30	by	by	ADP
globalce-210	57	31	research	research	NOUN
globalce-210	57	32	.	.	PUNCT
globalce-210	58	1	if	if	SCONJ
globalce-210	58	2	smpc	smpc	ADJ
globalce-210	58	3	recommendations	recommendation	NOUN
globalce-210	58	4	,	,	PUNCT
globalce-210	58	5	such	such	ADJ
globalce-210	58	6	as	as	ADP
globalce-210	58	7	posology	posology	NOUN
globalce-210	58	8	or	or	CCONJ
globalce-210	58	9	monitoring	monitor	VERB
globalce-210	58	10	incorporate	incorporate	VERB
globalce-210	58	11	advice	advice	NOUN
globalce-210	58	12	from	from	ADP
globalce-210	58	13	an	an	DET
globalce-210	58	14	ai	ai	NOUN
globalce-210	58	15	-	-	PUNCT
globalce-210	58	16	enabled	enable	VERB
globalce-210	58	17	medical	medical	ADJ
globalce-210	58	18	device	device	NOUN
globalce-210	58	19	,	,	PUNCT
globalce-210	58	20	all	all	DET
globalce-210	58	21	relevant	relevant	ADJ
globalce-210	58	22	aspects	aspect	NOUN
globalce-210	58	23	of	of	ADP
globalce-210	58	24	that	that	DET
globalce-210	58	25	combination	combination	NOUN
globalce-210	58	26	are	be	AUX
globalce-210	58	27	considered	consider	VERB
globalce-210	58	28	during	during	ADP
globalce-210	58	29	assessment	assessment	NOUN
globalce-210	58	30	by	by	ADP
globalce-210	58	31	the	the	DET
globalce-210	58	32	ema.17	ema.17	PROPN
globalce-210	58	33	according	accord	VERB
globalce-210	58	34	to	to	ADP
globalce-210	58	35	this	this	DET
globalce-210	58	36	reflection	reflection	NOUN
globalce-210	58	37	paper	paper	NOUN
globalce-210	58	38	,	,	PUNCT
globalce-210	58	39	general	general	ADJ
globalce-210	58	40	guidelines	guideline	NOUN
globalce-210	58	41	and	and	CCONJ
globalce-210	58	42	expectations	expectation	NOUN
globalce-210	58	43	applicable	applicable	ADJ
globalce-210	58	44	for	for	ADP
globalce-210	58	45	medical	medical	ADJ
globalce-210	58	46	devices	device	NOUN
globalce-210	58	47	would	would	AUX
globalce-210	58	48	also	also	ADV
globalce-210	58	49	apply	apply	VERB
globalce-210	58	50	to	to	ADP
globalce-210	58	51	the	the	DET
globalce-210	58	52	clinical	clinical	ADJ
globalce-210	58	53	trial	trial	NOUN
globalce-210	58	54	and	and	CCONJ
globalce-210	58	55	marketing	marketing	NOUN
globalce-210	58	56	authorization	authorization	NOUN
globalce-210	58	57	contexts	contexts	NOUN
globalce-210	58	58	using	use	VERB
globalce-210	58	59	ai	ai	VERB
globalce-210	58	60	/	/	SYM
globalce-210	58	61	ml	ml	VERB
globalce-210	58	62	-	-	PUNCT
globalce-210	58	63	based	base	VERB
globalce-210	58	64	approaches.18	approaches.18	ADJ
globalce-210	58	65	overall	overall	ADJ
globalce-210	58	66	,	,	PUNCT
globalce-210	58	67	the	the	DET
globalce-210	58	68	ema	ema	PROPN
globalce-210	58	69	is	be	AUX
globalce-210	58	70	adopting	adopt	VERB
globalce-210	58	71	a	a	DET
globalce-210	58	72	risk	risk	NOUN
globalce-210	58	73	-	-	PUNCT
globalce-210	58	74	based	base	VERB
globalce-210	58	75	strategy	strategy	NOUN
globalce-210	58	76	,	,	PUNCT
globalce-210	58	77	instructing	instruct	VERB
globalce-210	58	78	the	the	DET
globalce-210	58	79	sponsors	sponsor	NOUN
globalce-210	58	80	to	to	PART
globalce-210	58	81	consider	consider	VERB
globalce-210	58	82	whether	whether	SCONJ
globalce-210	58	83	the	the	DET
globalce-210	58	84	ai	ai	NOUN
globalce-210	58	85	system	system	NOUN
globalce-210	58	86	presents	present	VERB
globalce-210	58	87	risks	risk	NOUN
globalce-210	58	88	to	to	ADP
globalce-210	58	89	patients	patient	NOUN
globalce-210	58	90	,	,	PUNCT
globalce-210	58	91	and	and	CCONJ
globalce-210	58	92	if	if	SCONJ
globalce-210	58	93	so	so	ADV
globalce-210	58	94	,	,	PUNCT
globalce-210	58	95	then	then	ADV
globalce-210	58	96	to	to	PART
globalce-210	58	97	seek	seek	VERB
globalce-210	58	98	early	early	ADJ
globalce-210	58	99	regulatory	regulatory	ADJ
globalce-210	58	100	advice	advice	NOUN
globalce-210	58	101	from	from	ADP
globalce-210	58	102	the	the	DET
globalce-210	58	103	ema	ema	PROPN
globalce-210	58	104	.	.	PUNCT
globalce-210	59	1	the	the	DET
globalce-210	59	2	ema	ema	PROPN
globalce-210	59	3	is	be	AUX
globalce-210	59	4	getting	get	VERB
globalce-210	59	5	ready	ready	ADJ
globalce-210	59	6	to	to	PART
globalce-210	59	7	examine	examine	VERB
globalce-210	59	8	applications	application	NOUN
globalce-210	59	9	that	that	PRON
globalce-210	59	10	incorporate	incorporate	VERB
globalce-210	59	11	ai	ai	NOUN
globalce-210	59	12	/	/	SYM
globalce-210	59	13	ml	ml	NOUN
globalce-210	59	14	systems	system	NOUN
globalce-210	59	15	into	into	ADP
globalce-210	59	16	the	the	DET
globalce-210	59	17	lifecycle	lifecycle	NOUN
globalce-210	59	18	of	of	ADP
globalce-210	59	19	medical	medical	ADJ
globalce-210	59	20	products.19	products.19	NOUN
globalce-210	59	21	overview	overview	NOUN
globalce-210	59	22	of	of	ADP
globalce-210	59	23	the	the	DET
globalce-210	59	24	european	european	PROPN
globalce-210	59	25	medicines	medicines	PROPN
globalce-210	59	26	agency	agency	NOUN
globalce-210	59	27	’s	’s	PART
globalce-210	59	28	(	(	PUNCT
globalce-210	59	29	ema	ema	PROPN
globalce-210	59	30	)	)	PUNCT
globalce-210	59	31	reflection	reflection	NOUN
globalce-210	59	32	paper	paper	NOUN
globalce-210	59	33	the	the	DET
globalce-210	59	34	ema	ema	PROPN
globalce-210	59	35	has	have	AUX
globalce-210	59	36	released	release	VERB
globalce-210	59	37	a	a	DET
globalce-210	59	38	preliminary	preliminary	ADJ
globalce-210	59	39	document	document	NOUN
globalce-210	59	40	outlining	outline	VERB
globalce-210	59	41	its	its	PRON
globalce-210	59	42	current	current	ADJ
globalce-210	59	43	stance	stance	NOUN
globalce-210	59	44	on	on	ADP
globalce-210	59	45	the	the	DET
globalce-210	59	46	use	use	NOUN
globalce-210	59	47	of	of	ADP
globalce-210	59	48	ai	ai	NOUN
globalce-210	59	49	and	and	CCONJ
globalce-210	59	50	ml	ml	NOUN
globalce-210	59	51	to	to	PART
globalce-210	59	52	enhance	enhance	VERB
globalce-210	59	53	regulatory	regulatory	ADJ
globalce-210	59	54	approaches	approach	NOUN
globalce-210	59	55	to	to	PART
globalce-210	59	56	ai	ai	VERB
globalce-210	59	57	in	in	ADP
globalce-210	59	58	medical	medical	ADJ
globalce-210	59	59	devices	device	NOUN
globalce-210	59	60	artificial	artificial	ADJ
globalce-210	59	61	intelligence	intelligence	NOUN
globalce-210	59	62	in	in	ADP
globalce-210	59	63	medical	medical	ADJ
globalce-210	59	64	device	device	NOUN
globalce-210	59	65	regulations	regulation	NOUN
globalce-210	59	66	is	be	AUX
globalce-210	59	67	now	now	ADV
globalce-210	59	68	evolving	evolve	VERB
globalce-210	59	69	quickly	quickly	ADV
globalce-210	59	70	,	,	PUNCT
globalce-210	59	71	as	as	ADP
globalce-210	59	72	the	the	DET
globalce-210	59	73	eu	eu	PROPN
globalce-210	59	74	,	,	PUNCT
globalce-210	59	75	the	the	DET
globalce-210	59	76	united	united	PROPN
globalce-210	59	77	states	states	PROPN
globalce-210	59	78	,	,	PUNCT
globalce-210	59	79	and	and	CCONJ
globalce-210	59	80	india	india	PROPN
globalce-210	59	81	are	be	AUX
globalce-210	59	82	adopting	adopt	VERB
globalce-210	59	83	new	new	ADJ
globalce-210	59	84	pathways	pathway	NOUN
globalce-210	59	85	to	to	PART
globalce-210	59	86	ensure	ensure	VERB
globalce-210	59	87	that	that	SCONJ
globalce-210	59	88	these	these	DET
globalce-210	59	89	technologies	technology	NOUN
globalce-210	59	90	are	be	AUX
globalce-210	59	91	safe	safe	ADJ
globalce-210	59	92	and	and	CCONJ
globalce-210	59	93	effective	effective	ADJ
globalce-210	59	94	.	.	PUNCT
globalce-210	60	1	the	the	DET
globalce-210	60	2	eu	eu	PROPN
globalce-210	60	3	is	be	AUX
globalce-210	60	4	developing	develop	VERB
globalce-210	60	5	a	a	DET
globalce-210	60	6	comprehensive	comprehensive	ADJ
globalce-210	60	7	ai	ai	PROPN
globalce-210	60	8	act	act	PROPN
globalce-210	60	9	,	,	PUNCT
globalce-210	60	10	which	which	PRON
globalce-210	60	11	sets	set	VERB
globalce-210	60	12	out	out	ADP
globalce-210	60	13	strict	strict	ADJ
globalce-210	60	14	rules	rule	NOUN
globalce-210	60	15	on	on	ADP
globalce-210	60	16	any	any	DET
globalce-210	60	17	use	use	NOUN
globalce-210	60	18	of	of	ADP
globalce-210	60	19	the	the	DET
globalce-210	60	20	technology	technology	NOUN
globalce-210	60	21	,	,	PUNCT
globalce-210	60	22	while	while	SCONJ
globalce-210	60	23	the	the	DET
globalce-210	60	24	united	united	PROPN
globalce-210	60	25	states	states	PROPN
globalce-210	60	26	continues	continue	VERB
globalce-210	60	27	to	to	PART
globalce-210	60	28	rely	rely	VERB
globalce-210	60	29	on	on	ADP
globalce-210	60	30	its	its	PRON
globalce-210	60	31	existing	exist	VERB
globalce-210	60	32	regulations	regulation	NOUN
globalce-210	60	33	and	and	CCONJ
globalce-210	60	34	guidelines	guideline	NOUN
globalce-210	60	35	.	.	PUNCT
globalce-210	61	1	india	india	PROPN
globalce-210	61	2	is	be	AUX
globalce-210	61	3	aligning	align	VERB
globalce-210	61	4	its	its	PRON
globalce-210	61	5	regulatory	regulatory	ADJ
globalce-210	61	6	framework	framework	NOUN
globalce-210	61	7	with	with	ADP
globalce-210	61	8	international	international	ADJ
globalce-210	61	9	standards	standard	NOUN
globalce-210	61	10	,	,	PUNCT
globalce-210	61	11	particularly	particularly	ADV
globalce-210	61	12	those	those	PRON
globalce-210	61	13	set	set	VERB
globalce-210	61	14	by	by	ADP
globalce-210	61	15	the	the	DET
globalce-210	61	16	international	international	ADJ
globalce-210	61	17	medical	medical	ADJ
globalce-210	61	18	device	device	NOUN
globalce-210	61	19	regulators	regulator	NOUN
globalce-210	61	20	forum	forum	NOUN
globalce-210	61	21	(	(	PUNCT
globalce-210	61	22	imdrf).11	imdrf).11	PROPN
globalce-210	61	23	these	these	DET
globalce-210	61	24	regulatory	regulatory	ADJ
globalce-210	61	25	mechanisms	mechanism	NOUN
globalce-210	61	26	play	play	VERB
globalce-210	61	27	an	an	DET
globalce-210	61	28	important	important	ADJ
globalce-210	61	29	role	role	NOUN
globalce-210	61	30	in	in	ADP
globalce-210	61	31	preventing	prevent	VERB
globalce-210	61	32	the	the	DET
globalce-210	61	33	operational	operational	ADJ
globalce-210	61	34	and	and	CCONJ
globalce-210	61	35	planning	planning	NOUN
globalce-210	61	36	data	datum	NOUN
globalce-210	61	37	management	management	NOUN
globalce-210	61	38	system	system	NOUN
globalce-210	61	39	from	from	ADP
globalce-210	61	40	becoming	become	VERB
globalce-210	61	41	points	point	NOUN
globalce-210	61	42	of	of	ADP
globalce-210	61	43	failure	failure	NOUN
globalce-210	61	44	,	,	PUNCT
globalce-210	61	45	and	and	CCONJ
globalce-210	61	46	thus	thus	ADV
globalce-210	61	47	protect	protect	VERB
globalce-210	61	48	patients	patient	NOUN
globalce-210	61	49	as	as	ADV
globalce-210	61	50	well	well	ADV
globalce-210	61	51	as	as	ADP
globalce-210	61	52	healthcare	healthcare	NOUN
globalce-210	61	53	practitioners	practitioner	NOUN
globalce-210	61	54	by	by	ADP
globalce-210	61	55	determining	determine	VERB
globalce-210	61	56	that	that	DET
globalce-210	61	57	medical	medical	ADJ
globalce-210	61	58	devices	device	NOUN
globalce-210	61	59	powered	power	VERB
globalce-210	61	60	with	with	ADP
globalce-210	61	61	ai	ai	PRON
globalce-210	61	62	underperform	underperform	NOUN
globalce-210	61	63	reliably.11	reliably.11	VERB
globalce-210	61	64	european	european	ADJ
globalce-210	61	65	union	union	PROPN
globalce-210	61	66	the	the	DET
globalce-210	61	67	eu	eu	PROPN
globalce-210	61	68	wants	want	VERB
globalce-210	61	69	to	to	PART
globalce-210	61	70	regulate	regulate	VERB
globalce-210	61	71	ai	ai	VERB
globalce-210	61	72	in	in	ADP
globalce-210	61	73	all	all	DET
globalce-210	61	74	areas	area	NOUN
globalce-210	61	75	,	,	PUNCT
globalce-210	61	76	including	include	VERB
globalce-210	61	77	healthcare	healthcare	NOUN
globalce-210	61	78	,	,	PUNCT
globalce-210	61	79	based	base	VERB
globalce-210	61	80	on	on	ADP
globalce-210	61	81	how	how	SCONJ
globalce-210	61	82	dangerous	dangerous	ADJ
globalce-210	61	83	it	it	PRON
globalce-210	61	84	is	be	AUX
globalce-210	61	85	.	.	PUNCT
globalce-210	62	1	the	the	DET
globalce-210	62	2	proposed	propose	VERB
globalce-210	62	3	ai	ai	PROPN
globalce-210	62	4	act	act	NOUN
globalce-210	62	5	wants	want	VERB
globalce-210	62	6	to	to	PART
globalce-210	62	7	make	make	VERB
globalce-210	62	8	a	a	DET
globalce-210	62	9	legal	legal	ADJ
globalce-210	62	10	definition	definition	NOUN
globalce-210	62	11	of	of	ADP
globalce-210	62	12	“	"	PUNCT
globalce-210	62	13	ai	ai	PROPN
globalce-210	62	14	system	system	NOUN
globalce-210	62	15	”	"	PUNCT
globalce-210	62	16	and	and	CCONJ
globalce-210	62	17	sets	set	VERB
globalce-210	62	18	rules	rule	NOUN
globalce-210	62	19	for	for	ADP
globalce-210	62	20	how	how	SCONJ
globalce-210	62	21	ai	ai	NOUN
globalce-210	62	22	can	can	AUX
globalce-210	62	23	be	be	AUX
globalce-210	62	24	built	build	VERB
globalce-210	62	25	into	into	ADP
globalce-210	62	26	and	and	CCONJ
globalce-210	62	27	used	use	VERB
globalce-210	62	28	in	in	ADP
globalce-210	62	29	medical	medical	ADJ
globalce-210	62	30	devices	device	NOUN
globalce-210	62	31	.	.	PUNCT
globalce-210	63	1	the	the	DET
globalce-210	63	2	eu	eu	PROPN
globalce-210	63	3	ai	ai	PROPN
globalce-210	63	4	act	act	NOUN
globalce-210	63	5	makes	make	VERB
globalce-210	63	6	sure	sure	ADJ
globalce-210	63	7	that	that	SCONJ
globalce-210	63	8	ai	ai	AUX
globalce-210	63	9	systems	system	NOUN
globalce-210	63	10	follow	follow	VERB
globalce-210	63	11	basic	basic	ADJ
globalce-210	63	12	rights	right	NOUN
globalce-210	63	13	,	,	PUNCT
globalce-210	63	14	safety	safety	NOUN
globalce-210	63	15	rules	rule	NOUN
globalce-210	63	16	,	,	PUNCT
globalce-210	63	17	and	and	CCONJ
globalce-210	63	18	morals	moral	NOUN
globalce-210	63	19	by	by	ADP
globalce-210	63	20	setting	set	VERB
globalce-210	63	21	clear	clear	ADJ
globalce-210	63	22	rules	rule	NOUN
globalce-210	63	23	for	for	ADP
globalce-210	63	24	how	how	SCONJ
globalce-210	63	25	they	they	PRON
globalce-210	63	26	can	can	AUX
globalce-210	63	27	work.12	work.12	NOUN
globalce-210	63	28	overview	overview	VERB
globalce-210	63	29	of	of	ADP
globalce-210	63	30	the	the	DET
globalce-210	63	31	european	european	PROPN
globalce-210	63	32	medicines	medicines	PROPN
globalce-210	63	33	agency	agency	NOUN
globalce-210	63	34	’s	’s	PART
globalce-210	63	35	(	(	PUNCT
globalce-210	63	36	ema	ema	PROPN
globalce-210	63	37	)	)	PUNCT
globalce-210	63	38	reflection	reflection	NOUN
globalce-210	63	39	paper	paper	NOUN
globalce-210	63	40	the	the	DET
globalce-210	63	41	ema	ema	PROPN
globalce-210	63	42	has	have	AUX
globalce-210	63	43	published	publish	VERB
globalce-210	63	44	a	a	DET
globalce-210	63	45	preliminary	preliminary	ADJ
globalce-210	63	46	document	document	NOUN
globalce-210	63	47	discussing	discuss	VERB
globalce-210	63	48	the	the	DET
globalce-210	63	49	use	use	NOUN
globalce-210	63	50	of	of	ADP
globalce-210	63	51	ai	ai	NOUN
globalce-210	63	52	and	and	CCONJ
globalce-210	63	53	ml	ml	NOUN
globalce-210	63	54	in	in	ADP
globalce-210	63	55	the	the	DET
globalce-210	63	56	entire	entire	ADJ
globalce-210	63	57	lifespan	lifespan	NOUN
globalce-210	63	58	of	of	ADP
globalce-210	63	59	medicinal	medicinal	ADJ
globalce-210	63	60	products	product	NOUN
globalce-210	63	61	,	,	PUNCT
globalce-210	63	62	including	include	VERB
globalce-210	63	63	those	those	PRON
globalce-210	63	64	for	for	ADP
globalce-210	63	65	human	human	ADJ
globalce-210	63	66	and	and	CCONJ
globalce-210	63	67	veterinary	veterinary	ADJ
globalce-210	63	68	use.13	use.13	PRON
globalce-210	63	69	the	the	DET
globalce-210	63	70	use	use	NOUN
globalce-210	63	71	of	of	ADP
globalce-210	63	72	ai	ai	VERB
globalce-210	63	73	/	/	SYM
globalce-210	63	74	ml	ml	NOUN
globalce-210	63	75	systems	system	NOUN
globalce-210	63	76	for	for	ADP
globalce-210	63	77	the	the	DET
globalce-210	63	78	clinical	clinical	ADJ
globalce-210	63	79	management	management	NOUN
globalce-210	63	80	of	of	ADP
globalce-210	63	81	individual	individual	ADJ
globalce-210	63	82	patients	patient	NOUN
globalce-210	63	83	may	may	AUX
globalce-210	63	84	result	result	VERB
globalce-210	63	85	in	in	ADP
globalce-210	63	86	the	the	DET
globalce-210	63	87	medical	medical	ADJ
globalce-210	63	88	device	device	NOUN
globalce-210	63	89	regulation	regulation	NOUN
globalce-210	63	90	(	(	PUNCT
globalce-210	63	91	mdr	mdr	NOUN
globalce-210	63	92	)	)	PUNCT
globalce-210	63	93	classifying	classify	VERB
globalce-210	63	94	in	in	ADP
globalce-210	63	95	vitro	vitro	X
globalce-210	63	96	diagnostics	diagnostic	NOUN
globalce-210	63	97	(	(	PUNCT
globalce-210	63	98	ivds	ivds	NOUN
globalce-210	63	99	)	)	PUNCT
globalce-210	63	100	used	use	VERB
globalce-210	63	101	in	in	ADP
globalce-210	63	102	performance	performance	NOUN
globalce-210	63	103	evaluation	evaluation	NOUN
globalce-210	63	104	as	as	ADP
globalce-210	63	105	medical	medical	ADJ
globalce-210	63	106	devices	device	NOUN
globalce-210	63	107	,	,	PUNCT
globalce-210	63	108	as	as	SCONJ
globalce-210	63	109	stated	state	VERB
globalce-210	63	110	in	in	ADP
globalce-210	63	111	the	the	DET
globalce-210	63	112	reflection	reflection	NOUN
globalce-210	63	113	paper	paper	NOUN
globalce-210	63	114	.	.	PUNCT
globalce-210	64	1	a	a	DET
globalce-210	64	2	document	document	NOUN
globalce-210	64	3	issued	issue	VERB
globalce-210	64	4	by	by	ADP
globalce-210	64	5	the	the	DET
globalce-210	64	6	medical	medical	ADJ
globalce-210	64	7	device	device	NOUN
globalce-210	64	8	coordination	coordination	NOUN
globalce-210	64	9	group	group	NOUN
globalce-210	64	10	(	(	PUNCT
globalce-210	64	11	mdcg	mdcg	ADJ
globalce-210	64	12	)	)	PUNCT
globalce-210	64	13	offers	offer	VERB
globalce-210	64	14	detailed	detailed	ADJ
globalce-210	64	15	guidelines	guideline	NOUN
globalce-210	64	16	on	on	ADP
globalce-210	64	17	the	the	DET
globalce-210	64	18	qualification	qualification	NOUN
globalce-210	64	19	and	and	CCONJ
globalce-210	64	20	classification	classification	NOUN
globalce-210	64	21	of	of	ADP
globalce-210	64	22	software	software	NOUN
globalce-210	64	23	as	as	ADP
globalce-210	64	24	medical	medical	ADJ
globalce-210	64	25	devices	device	NOUN
globalce-210	64	26	in	in	ADP
globalce-210	64	27	accordance	accordance	NOUN
globalce-210	64	28	with	with	ADP
globalce-210	64	29	the	the	DET
globalce-210	64	30	mdr	mdr	PROPN
globalce-210	64	31	,	,	PUNCT
globalce-210	64	32	the	the	DET
globalce-210	64	33	in	in	X
globalce-210	64	34	vitro	vitro	X
globalce-210	64	35	diagnostic	diagnostic	ADJ
globalce-210	64	36	devices	device	NOUN
globalce-210	64	37	regulation	regulation	NOUN
globalce-210	64	38	(	(	PUNCT
globalce-210	64	39	ivdr	ivdr	ADJ
globalce-210	64	40	)	)	PUNCT
globalce-210	64	41	,	,	PUNCT
globalce-210	64	42	or	or	CCONJ
globalce-210	64	43	both.14	both.14	NOUN
globalce-210	64	44	nonetheless	nonetheless	ADV
globalce-210	64	45	ema	ema	PROPN
globalce-210	64	46	has	have	VERB
globalce-210	64	47	no	no	DET
globalce-210	64	48	responsibility	responsibility	NOUN
globalce-210	64	49	to	to	PART
globalce-210	64	50	classify	classify	VERB
globalce-210	64	51	software	software	NOUN
globalce-210	64	52	by	by	ADP
globalce-210	64	53	the	the	DET
globalce-210	64	54	rules	rule	NOUN
globalce-210	64	55	.	.	PUNCT
globalce-210	65	1	additional	additional	ADJ
globalce-210	65	2	prerequisites	prerequisite	NOUN
globalce-210	65	3	are	be	AUX
globalce-210	65	4	15	15	NUM
globalce-210	65	5	j	j	PROPN
globalce-210	65	6	global	global	ADJ
globalce-210	65	7	clinical	clinical	ADJ
globalce-210	65	8	engineering	engineering	NOUN
globalce-210	65	9	vol.7	vol.7	PROPN
globalce-210	65	10	issue	issue	NOUN
globalce-210	65	11	2	2	NUM
globalce-210	65	12	:	:	SYM
globalce-210	65	13	2025	2025	NUM
globalce-210	65	14	gaur	gaur	NOUN
globalce-210	65	15	,	,	PUNCT
globalce-210	65	16	akram	akram	PROPN
globalce-210	65	17	,	,	PUNCT
globalce-210	65	18	singh	singh	PROPN
globalce-210	65	19	,	,	PUNCT
globalce-210	65	20	chauhan	chauhan	PROPN
globalce-210	65	21	:	:	PUNCT
globalce-210	65	22	artificial	artificial	ADJ
globalce-210	65	23	intelligence	intelligence	NOUN
globalce-210	65	24	-	-	PUNCT
globalce-210	65	25	driven	drive	VERB
globalce-210	65	26	insights	insight	NOUN
globalce-210	65	27	for	for	ADP
globalce-210	65	28	regulatory	regulatory	ADJ
globalce-210	65	29	intelligence	intelligence	NOUN
globalce-210	65	30	in	in	ADP
globalce-210	65	31	medical	medical	ADJ
globalce-210	65	32	devices	device	NOUN
globalce-210	65	33	:	:	PUNCT
globalce-210	65	34	evaluating	evaluate	VERB
globalce-210	65	35	ema	ema	PROPN
globalce-210	65	36	,	,	PUNCT
globalce-210	65	37	fda	fda	PROPN
globalce-210	65	38	,	,	PUNCT
globalce-210	65	39	and	and	CCONJ
globalce-210	65	40	cdsco	cdsco	NOUN
globalce-210	65	41	frameworks	framework	VERB
globalce-210	65	42	the	the	DET
globalce-210	65	43	safe	safe	ADJ
globalce-210	65	44	and	and	CCONJ
globalce-210	65	45	efficient	efficient	ADJ
globalce-210	65	46	development	development	NOUN
globalce-210	65	47	,	,	PUNCT
globalce-210	65	48	regulation	regulation	NOUN
globalce-210	65	49	,	,	PUNCT
globalce-210	65	50	and	and	CCONJ
globalce-210	65	51	use	use	NOUN
globalce-210	65	52	of	of	ADP
globalce-210	65	53	human	human	ADJ
globalce-210	65	54	and	and	CCONJ
globalce-210	65	55	veterinary	veterinary	ADJ
globalce-210	65	56	medicines	medicine	NOUN
globalce-210	65	57	throughout	throughout	ADP
globalce-210	65	58	the	the	DET
globalce-210	65	59	lifespan	lifespan	NOUN
globalce-210	65	60	of	of	ADP
globalce-210	65	61	the	the	DET
globalce-210	65	62	product	product	NOUN
globalce-210	65	63	.	.	PUNCT
globalce-210	66	1	the	the	DET
globalce-210	66	2	ema	ema	PROPN
globalce-210	66	3	acknowledges	acknowledge	VERB
globalce-210	66	4	the	the	DET
globalce-210	66	5	potential	potential	NOUN
globalce-210	66	6	of	of	ADP
globalce-210	66	7	ai	ai	VERB
globalce-210	66	8	to	to	PART
globalce-210	66	9	improve	improve	VERB
globalce-210	66	10	different	different	ADJ
globalce-210	66	11	areas	area	NOUN
globalce-210	66	12	of	of	ADP
globalce-210	66	13	the	the	DET
globalce-210	66	14	pharmaceutical	pharmaceutical	NOUN
globalce-210	66	15	industry	industry	NOUN
globalce-210	66	16	,	,	PUNCT
globalce-210	66	17	such	such	ADJ
globalce-210	66	18	as	as	ADP
globalce-210	66	19	drug	drug	NOUN
globalce-210	66	20	discovery	discovery	NOUN
globalce-210	66	21	,	,	PUNCT
globalce-210	66	22	preclinical	preclinical	ADJ
globalce-210	66	23	development	development	NOUN
globalce-210	66	24	,	,	PUNCT
globalce-210	66	25	clinical	clinical	ADJ
globalce-210	66	26	trials	trial	NOUN
globalce-210	66	27	,	,	PUNCT
globalce-210	66	28	precision	precision	NOUN
globalce-210	66	29	medicine	medicine	NOUN
globalce-210	66	30	,	,	PUNCT
globalce-210	66	31	product	product	NOUN
globalce-210	66	32	information	information	NOUN
globalce-210	66	33	,	,	PUNCT
globalce-210	66	34	manufacturing	manufacturing	NOUN
globalce-210	66	35	,	,	PUNCT
globalce-210	66	36	and	and	CCONJ
globalce-210	66	37	post	post	ADJ
globalce-210	66	38	-	-	ADJ
globalce-210	66	39	approval	approval	ADJ
globalce-210	66	40	pharmacovigilance.20	pharmacovigilance.20	PROPN
globalce-210	66	41	nevertheless	nevertheless	ADV
globalce-210	66	42	,	,	PUNCT
globalce-210	66	43	the	the	DET
globalce-210	66	44	agency	agency	NOUN
globalce-210	66	45	underscores	underscore	VERB
globalce-210	66	46	the	the	DET
globalce-210	66	47	importance	importance	NOUN
globalce-210	66	48	of	of	ADP
globalce-210	66	49	adopting	adopt	VERB
globalce-210	66	50	a	a	DET
globalce-210	66	51	human	human	NOUN
globalce-210	66	52	-	-	PUNCT
globalce-210	66	53	centered	center	VERB
globalce-210	66	54	approach	approach	NOUN
globalce-210	66	55	in	in	ADP
globalce-210	66	56	all	all	DET
globalce-210	66	57	aspects	aspect	NOUN
globalce-210	66	58	of	of	ADP
globalce-210	66	59	ai	ai	NOUN
globalce-210	66	60	and	and	CCONJ
globalce-210	66	61	ml	ml	ADP
globalce-210	66	62	development	development	NOUN
globalce-210	66	63	and	and	CCONJ
globalce-210	66	64	implementation	implementation	NOUN
globalce-210	66	65	.	.	PUNCT
globalce-210	67	1	it	it	PRON
globalce-210	67	2	is	be	AUX
globalce-210	67	3	crucial	crucial	ADJ
globalce-210	67	4	to	to	PART
globalce-210	67	5	adhere	adhere	VERB
globalce-210	67	6	to	to	ADP
globalce-210	67	7	the	the	DET
globalce-210	67	8	existing	exist	VERB
globalce-210	67	9	legal	legal	ADJ
globalce-210	67	10	obligations	obligation	NOUN
globalce-210	67	11	,	,	PUNCT
globalce-210	67	12	prioritize	prioritize	VERB
globalce-210	67	13	ethical	ethical	ADJ
globalce-210	67	14	considerations	consideration	NOUN
globalce-210	67	15	,	,	PUNCT
globalce-210	67	16	and	and	CCONJ
globalce-210	67	17	uphold	uphold	VERB
globalce-210	67	18	fundamental	fundamental	ADJ
globalce-210	67	19	rights	right	NOUN
globalce-210	67	20	.	.	PUNCT
globalce-210	68	1	the	the	DET
globalce-210	68	2	ema	ema	PROPN
globalce-210	68	3	promotes	promote	VERB
globalce-210	68	4	transparency	transparency	NOUN
globalce-210	68	5	and	and	CCONJ
globalce-210	68	6	comprehensibility	comprehensibility	NOUN
globalce-210	68	7	in	in	ADP
globalce-210	68	8	the	the	DET
globalce-210	68	9	creation	creation	NOUN
globalce-210	68	10	and	and	CCONJ
globalce-210	68	11	verification	verification	NOUN
globalce-210	68	12	of	of	ADP
globalce-210	68	13	ai	ai	PROPN
globalce-210	68	14	systems.21	systems.21	NOUN
globalce-210	68	15	this	this	PRON
globalce-210	68	16	entails	entail	VERB
globalce-210	68	17	providing	provide	VERB
globalce-210	68	18	explicit	explicit	ADJ
globalce-210	68	19	documentation	documentation	NOUN
globalce-210	68	20	of	of	ADP
globalce-210	68	21	the	the	DET
globalce-210	68	22	utilized	utilize	VERB
globalce-210	68	23	data	datum	NOUN
globalce-210	68	24	,	,	PUNCT
globalce-210	68	25	applied	apply	VERB
globalce-210	68	26	algorithms	algorithm	NOUN
globalce-210	68	27	,	,	PUNCT
globalce-210	68	28	and	and	CCONJ
globalce-210	68	29	achieved	achieve	VERB
globalce-210	68	30	performance	performance	NOUN
globalce-210	68	31	,	,	PUNCT
globalce-210	68	32	with	with	ADP
globalce-210	68	33	the	the	DET
globalce-210	68	34	level	level	NOUN
globalce-210	68	35	of	of	ADP
globalce-210	68	36	explanation	explanation	NOUN
globalce-210	68	37	aligning	align	VERB
globalce-210	68	38	with	with	ADP
globalce-210	68	39	the	the	DET
globalce-210	68	40	level	level	NOUN
globalce-210	68	41	of	of	ADP
globalce-210	68	42	risk	risk	NOUN
globalce-210	68	43	.	.	PUNCT
globalce-210	69	1	sponsors	sponsor	NOUN
globalce-210	69	2	should	should	AUX
globalce-210	69	3	utilize	utilize	VERB
globalce-210	69	4	reliable	reliable	ADJ
globalce-210	69	5	and	and	CCONJ
globalce-210	69	6	accurate	accurate	ADJ
globalce-210	69	7	data	datum	NOUN
globalce-210	69	8	when	when	SCONJ
globalce-210	69	9	creating	create	VERB
globalce-210	69	10	and	and	CCONJ
globalce-210	69	11	testing	testing	NOUN
globalce-210	69	12	ai	ai	PROPN
globalce-210	69	13	systems	system	NOUN
globalce-210	69	14	,	,	PUNCT
globalce-210	69	15	carefully	carefully	ADV
globalce-210	69	16	choose	choose	VERB
globalce-210	69	17	and	and	CCONJ
globalce-210	69	18	validate	validate	VERB
globalce-210	69	19	algorithms	algorithm	NOUN
globalce-210	69	20	for	for	ADP
globalce-210	69	21	specific	specific	ADJ
globalce-210	69	22	purposes	purpose	NOUN
globalce-210	69	23	,	,	PUNCT
globalce-210	69	24	establish	establish	VERB
globalce-210	69	25	continuous	continuous	ADJ
globalce-210	69	26	monitoring	monitoring	NOUN
globalce-210	69	27	and	and	CCONJ
globalce-210	69	28	maintenance	maintenance	NOUN
globalce-210	69	29	plans	plan	NOUN
globalce-210	69	30	to	to	PART
globalce-210	69	31	identify	identify	VERB
globalce-210	69	32	and	and	CCONJ
globalce-210	69	33	address	address	VERB
globalce-210	69	34	any	any	DET
globalce-210	69	35	decline	decline	NOUN
globalce-210	69	36	in	in	ADP
globalce-210	69	37	performance	performance	NOUN
globalce-210	69	38	over	over	ADP
globalce-210	69	39	time	time	NOUN
globalce-210	69	40	,	,	PUNCT
globalce-210	69	41	conduct	conduct	VERB
globalce-210	69	42	thorough	thorough	ADJ
globalce-210	69	43	risk	risk	NOUN
globalce-210	69	44	assessments	assessment	NOUN
globalce-210	69	45	,	,	PUNCT
globalce-210	69	46	and	and	CCONJ
globalce-210	69	47	take	take	VERB
globalce-210	69	48	necessary	necessary	ADJ
globalce-210	69	49	measures	measure	NOUN
globalce-210	69	50	to	to	PART
globalce-210	69	51	mitigate	mitigate	VERB
globalce-210	69	52	risks	risk	NOUN
globalce-210	69	53	,	,	PUNCT
globalce-210	69	54	and	and	CCONJ
globalce-210	69	55	proactively	proactively	ADV
globalce-210	69	56	collaborate	collaborate	VERB
globalce-210	69	57	with	with	ADP
globalce-210	69	58	regulators	regulator	NOUN
globalce-210	69	59	to	to	PART
globalce-210	69	60	ensure	ensure	VERB
globalce-210	69	61	compliance	compliance	NOUN
globalce-210	69	62	with	with	ADP
globalce-210	69	63	ai	ai	ADJ
globalce-210	69	64	-	-	PUNCT
globalce-210	69	65	usage	usage	NOUN
globalce-210	69	66	guidelines	guideline	NOUN
globalce-210	69	67	.	.	PUNCT
globalce-210	70	1	the	the	DET
globalce-210	70	2	ema	ema	PROPN
globalce-210	70	3	’s	’s	PART
globalce-210	70	4	preliminary	preliminary	ADJ
globalce-210	70	5	reflection	reflection	NOUN
globalce-210	70	6	paper	paper	NOUN
globalce-210	70	7	was	be	AUX
globalce-210	70	8	available	available	ADJ
globalce-210	70	9	for	for	ADP
globalce-210	70	10	public	public	ADJ
globalce-210	70	11	consultation	consultation	NOUN
globalce-210	70	12	until	until	ADP
globalce-210	70	13	december	december	PROPN
globalce-210	70	14	31	31	NUM
globalce-210	70	15	,	,	PUNCT
globalce-210	70	16	2023.22	2023.22	NUM
globalce-210	70	17	us	we	PRON
globalce-210	70	18	food	food	NOUN
globalce-210	70	19	and	and	CCONJ
globalce-210	70	20	drug	drug	PROPN
globalce-210	70	21	administration	administration	PROPN
globalce-210	70	22	the	the	DET
globalce-210	70	23	us	us	PROPN
globalce-210	70	24	fda	fda	PROPN
globalce-210	70	25	regulates	regulate	VERB
globalce-210	70	26	the	the	DET
globalce-210	70	27	utilization	utilization	NOUN
globalce-210	70	28	of	of	ADP
globalce-210	70	29	ai	ai	VERB
globalce-210	70	30	in	in	ADP
globalce-210	70	31	medical	medical	ADJ
globalce-210	70	32	devices	device	NOUN
globalce-210	70	33	.	.	PUNCT
globalce-210	71	1	the	the	DET
globalce-210	71	2	fda	fda	PROPN
globalce-210	71	3	evaluates	evaluate	NOUN
globalce-210	71	4	ai	ai	VERB
globalce-210	71	5	/	/	SYM
globalce-210	71	6	ml	ml	VERB
globalce-210	71	7	-	-	PUNCT
globalce-210	71	8	enabled	enable	VERB
globalce-210	71	9	medical	medical	ADJ
globalce-210	71	10	devices	device	NOUN
globalce-210	71	11	based	base	VERB
globalce-210	71	12	on	on	ADP
globalce-210	71	13	their	their	PRON
globalce-210	71	14	use	use	NOUN
globalce-210	71	15	,	,	PUNCT
globalce-210	71	16	using	use	VERB
globalce-210	71	17	appropriate	appropriate	ADJ
globalce-210	71	18	premarket	premarket	NOUN
globalce-210	71	19	pathways	pathway	NOUN
globalce-210	71	20	,	,	PUNCT
globalce-210	71	21	such	such	ADJ
globalce-210	71	22	as	as	ADP
globalce-210	71	23	510(k	510(k	NUM
globalce-210	71	24	)	)	PUNCT
globalce-210	71	25	clearance	clearance	NOUN
globalce-210	71	26	and	and	CCONJ
globalce-210	71	27	de	de	ADP
globalce-210	71	28	novo	novo	NOUN
globalce-210	71	29	classification	classification	NOUN
globalce-210	71	30	for	for	ADP
globalce-210	71	31	noncontroversial	noncontroversial	ADJ
globalce-210	71	32	new	new	ADJ
globalce-210	71	33	technologies	technology	NOUN
globalce-210	71	34	,	,	PUNCT
globalce-210	71	35	and	and	CCONJ
globalce-210	71	36	traditional	traditional	ADJ
globalce-210	71	37	pma	pma	NOUN
globalce-210	71	38	for	for	ADP
globalce-210	71	39	innovative	innovative	NOUN
globalce-210	71	40	devices.23	devices.23	PROPN
globalce-210	71	41	the	the	DET
globalce-210	71	42	regulations	regulation	NOUN
globalce-210	71	43	governing	govern	VERB
globalce-210	71	44	medical	medical	ADJ
globalce-210	71	45	devices	device	NOUN
globalce-210	71	46	are	be	AUX
globalce-210	71	47	highly	highly	ADV
globalce-210	71	48	specific	specific	ADJ
globalce-210	71	49	.	.	PUNCT
globalce-210	72	1	the	the	DET
globalce-210	72	2	agency	agency	NOUN
globalce-210	72	3	provides	provide	VERB
globalce-210	72	4	detailed	detailed	ADJ
globalce-210	72	5	recommendations	recommendation	NOUN
globalce-210	72	6	and	and	CCONJ
globalce-210	72	7	action	action	NOUN
globalce-210	72	8	plans	plan	NOUN
globalce-210	72	9	for	for	ADP
globalce-210	72	10	regulatory	regulatory	ADJ
globalce-210	72	11	consideration	consideration	NOUN
globalce-210	72	12	in	in	ADP
globalce-210	72	13	response	response	NOUN
globalce-210	72	14	to	to	ADP
globalce-210	72	15	the	the	DET
globalce-210	72	16	challenges	challenge	NOUN
globalce-210	72	17	posed	pose	VERB
globalce-210	72	18	by	by	ADP
globalce-210	72	19	the	the	DET
globalce-210	72	20	rapidly	rapidly	ADV
globalce-210	72	21	evolving	evolve	VERB
globalce-210	72	22	field	field	NOUN
globalce-210	72	23	of	of	ADP
globalce-210	72	24	ai	ai	PROPN
globalce-210	72	25	technologies	technology	NOUN
globalce-210	72	26	.	.	PUNCT
globalce-210	73	1	these	these	PRON
globalce-210	73	2	encompass	encompass	VERB
globalce-210	73	3	the	the	DET
globalce-210	73	4	ai	ai	NOUN
globalce-210	73	5	and	and	CCONJ
globalce-210	73	6	software	software	NOUN
globalce-210	73	7	as	as	ADP
globalce-210	73	8	a	a	DET
globalce-210	73	9	medical	medical	ADJ
globalce-210	73	10	device	device	NOUN
globalce-210	73	11	action	action	NOUN
globalce-210	73	12	plan	plan	NOUN
globalce-210	73	13	,	,	PUNCT
globalce-210	73	14	along	along	ADP
globalce-210	73	15	with	with	ADP
globalce-210	73	16	supplementary	supplementary	ADJ
globalce-210	73	17	guidance	guidance	NOUN
globalce-210	73	18	on	on	ADP
globalce-210	73	19	ml	ml	NOUN
globalce-210	73	20	best	good	ADJ
globalce-210	73	21	practices	practice	NOUN
globalce-210	73	22	,	,	PUNCT
globalce-210	73	23	pre	pre	ADJ
globalce-210	73	24	-	-	ADJ
globalce-210	73	25	specification	specification	ADJ
globalce-210	73	26	change	change	NOUN
globalce-210	73	27	control	control	NOUN
globalce-210	73	28	plans	plan	NOUN
globalce-210	73	29	,	,	PUNCT
globalce-210	73	30	and	and	CCONJ
globalce-210	73	31	transparency.24	transparency.24	PROPN
globalce-210	73	32	fda	fda	PROPN
globalce-210	73	33	guidelines	guideline	NOUN
globalce-210	73	34	for	for	ADP
globalce-210	73	35	ai	ai	NOUN
globalce-210	73	36	/	/	SYM
globalce-210	73	37	ml	ml	NOUN
globalce-210	73	38	-	-	PUNCT
globalce-210	73	39	based	base	VERB
globalce-210	73	40	software	software	NOUN
globalce-210	73	41	as	as	ADP
globalce-210	73	42	a	a	DET
globalce-210	73	43	medical	medical	ADJ
globalce-210	73	44	device	device	NOUN
globalce-210	73	45	software	software	NOUN
globalce-210	73	46	as	as	ADP
globalce-210	73	47	a	a	DET
globalce-210	73	48	medical	medical	ADJ
globalce-210	73	49	device	device	NOUN
globalce-210	73	50	is	be	AUX
globalce-210	73	51	a	a	DET
globalce-210	73	52	term	term	NOUN
globalce-210	73	53	coined	coin	VERB
globalce-210	73	54	by	by	ADP
globalce-210	73	55	the	the	DET
globalce-210	73	56	imdrf	imdrf	NOUN
globalce-210	73	57	to	to	PART
globalce-210	73	58	refer	refer	VERB
globalce-210	73	59	to	to	ADP
globalce-210	73	60	software	software	NOUN
globalce-210	73	61	that	that	PRON
globalce-210	73	62	is	be	AUX
globalce-210	73	63	specifically	specifically	ADV
globalce-210	73	64	created	create	VERB
globalce-210	73	65	for	for	ADP
globalce-210	73	66	medical	medical	ADJ
globalce-210	73	67	usage	usage	NOUN
globalce-210	73	68	and	and	CCONJ
globalce-210	73	69	can	can	AUX
globalce-210	73	70	function	function	VERB
globalce-210	73	71	on	on	ADP
globalce-210	73	72	its	its	PRON
globalce-210	73	73	own	own	ADJ
globalce-210	73	74	,	,	PUNCT
globalce-210	73	75	without	without	ADP
globalce-210	73	76	incorporating	incorporate	VERB
globalce-210	73	77	into	into	ADP
globalce-210	73	78	a	a	DET
globalce-210	73	79	physical	physical	ADJ
globalce-210	73	80	medical	medical	ADJ
globalce-210	73	81	device.25	device.25	NOUN
globalce-210	73	82	overview	overview	NOUN
globalce-210	73	83	of	of	ADP
globalce-210	73	84	the	the	DET
globalce-210	73	85	fda	fda	PROPN
globalce-210	73	86	guidelines	guideline	NOUN
globalce-210	73	87	for	for	ADP
globalce-210	73	88	ai	ai	NOUN
globalce-210	73	89	/	/	SYM
globalce-210	73	90	ml	ml	NOUN
globalce-210	73	91	-	-	PUNCT
globalce-210	73	92	based	base	VERB
globalce-210	73	93	samd	samd	NOUN
globalce-210	73	94	:	:	PUNCT
globalce-210	73	95	the	the	DET
globalce-210	73	96	fda	fda	PROPN
globalce-210	73	97	is	be	AUX
globalce-210	73	98	in	in	ADP
globalce-210	73	99	the	the	DET
globalce-210	73	100	process	process	NOUN
globalce-210	73	101	of	of	ADP
globalce-210	73	102	developing	develop	VERB
globalce-210	73	103	regulatory	regulatory	ADJ
globalce-210	73	104	pathways	pathway	NOUN
globalce-210	73	105	for	for	ADP
globalce-210	73	106	samd	samd	NOUN
globalce-210	73	107	driven	drive	VERB
globalce-210	73	108	by	by	ADP
globalce-210	73	109	ai	ai	PROPN
globalce-210	73	110	and	and	CCONJ
globalce-210	73	111	ml	ml	VERB
globalce-210	73	112	.	.	PUNCT
globalce-210	74	1	these	these	DET
globalce-210	74	2	pathways	pathway	NOUN
globalce-210	74	3	include	include	VERB
globalce-210	74	4	traditional	traditional	ADJ
globalce-210	74	5	premarket	premarket	NOUN
globalce-210	74	6	pathways	pathway	NOUN
globalce-210	74	7	,	,	PUNCT
globalce-210	74	8	such	such	ADJ
globalce-210	74	9	as	as	ADP
globalce-210	74	10	510(k	510(k	PROPN
globalce-210	74	11	)	)	PUNCT
globalce-210	74	12	clearance	clearance	NOUN
globalce-210	74	13	,	,	PUNCT
globalce-210	74	14	de	de	X
globalce-210	74	15	novo	novo	NOUN
globalce-210	74	16	classification	classification	NOUN
globalce-210	74	17	,	,	PUNCT
globalce-210	74	18	and	and	CCONJ
globalce-210	74	19	premarket	premarket	NOUN
globalce-210	74	20	approval	approval	NOUN
globalce-210	74	21	(	(	PUNCT
globalce-210	74	22	pma	pma	NOUN
globalce-210	74	23	)	)	PUNCT
globalce-210	74	24	.	.	PUNCT
globalce-210	75	1	recognizing	recognize	VERB
globalce-210	75	2	that	that	SCONJ
globalce-210	75	3	ai	ai	NOUN
globalce-210	75	4	/	/	SYM
globalce-210	75	5	ml	ml	NOUN
globalce-210	75	6	technologies	technology	NOUN
globalce-210	75	7	are	be	AUX
globalce-210	75	8	adaptive	adaptive	ADJ
globalce-210	75	9	by	by	ADP
globalce-210	75	10	design	design	NOUN
globalce-210	75	11	,	,	PUNCT
globalce-210	75	12	the	the	DET
globalce-210	75	13	fda	fda	PROPN
globalce-210	75	14	has	have	AUX
globalce-210	75	15	acknowledged	acknowledge	VERB
globalce-210	75	16	that	that	SCONJ
globalce-210	75	17	traditional	traditional	ADJ
globalce-210	75	18	regulatory	regulatory	ADJ
globalce-210	75	19	approaches	approach	NOUN
globalce-210	75	20	may	may	AUX
globalce-210	75	21	not	not	PART
globalce-210	75	22	be	be	AUX
globalce-210	75	23	sufficient	sufficient	ADJ
globalce-210	75	24	for	for	ADP
globalce-210	75	25	these	these	DET
globalce-210	75	26	devices	device	NOUN
globalce-210	75	27	.	.	PUNCT
globalce-210	76	1	this	this	PRON
globalce-210	76	2	is	be	AUX
globalce-210	76	3	particularly	particularly	ADV
globalce-210	76	4	important	important	ADJ
globalce-210	76	5	because	because	SCONJ
globalce-210	76	6	the	the	DET
globalce-210	76	7	fda	fda	PROPN
globalce-210	76	8	no	no	ADV
globalce-210	76	9	longer	long	ADV
globalce-210	76	10	believes	believe	VERB
globalce-210	76	11	that	that	SCONJ
globalce-210	76	12	the	the	DET
globalce-210	76	13	old	old	ADJ
globalce-210	76	14	requirement	requirement	NOUN
globalce-210	76	15	of	of	ADP
globalce-210	76	16	locking	lock	VERB
globalce-210	76	17	algorithms	algorithm	NOUN
globalce-210	76	18	post	post	NOUN
globalce-210	76	19	-	-	NOUN
globalce-210	76	20	training	training	NOUN
globalce-210	76	21	is	be	AUX
globalce-210	76	22	adequate	adequate	ADJ
globalce-210	76	23	.	.	PUNCT
globalce-210	77	1	instead	instead	ADV
globalce-210	77	2	,	,	PUNCT
globalce-210	77	3	they	they	PRON
globalce-210	77	4	are	be	AUX
globalce-210	77	5	moving	move	VERB
globalce-210	77	6	toward	toward	ADP
globalce-210	77	7	a	a	DET
globalce-210	77	8	more	more	ADV
globalce-210	77	9	adaptive	adaptive	ADJ
globalce-210	77	10	framework	framework	NOUN
globalce-210	77	11	that	that	PRON
globalce-210	77	12	allows	allow	VERB
globalce-210	77	13	algorithms	algorithm	NOUN
globalce-210	77	14	to	to	PART
globalce-210	77	15	undergo	undergo	VERB
globalce-210	77	16	modifications	modification	NOUN
globalce-210	77	17	under	under	ADP
globalce-210	77	18	predefined	predefined	ADJ
globalce-210	77	19	change	change	NOUN
globalce-210	77	20	control	control	NOUN
globalce-210	77	21	plans	plan	NOUN
globalce-210	77	22	,	,	PUNCT
globalce-210	77	23	ensuring	ensure	VERB
globalce-210	77	24	safety	safety	NOUN
globalce-210	77	25	and	and	CCONJ
globalce-210	77	26	effectiveness	effectiveness	NOUN
globalce-210	77	27	.	.	PUNCT
globalce-210	78	1	this	this	DET
globalce-210	78	2	approach	approach	NOUN
globalce-210	78	3	addresses	address	VERB
globalce-210	78	4	the	the	DET
globalce-210	78	5	specific	specific	ADJ
globalce-210	78	6	challenges	challenge	NOUN
globalce-210	78	7	posed	pose	VERB
globalce-210	78	8	by	by	ADP
globalce-210	78	9	ai	ai	VERB
globalce-210	78	10	/	/	SYM
globalce-210	78	11	ml	ml	NOUN
globalce-210	78	12	medical	medical	ADJ
globalce-210	78	13	devices.26	devices.26	PROPN
globalce-210	78	14	important	important	ADJ
globalce-210	78	15	fda	fda	PROPN
globalce-210	78	16	guidance	guidance	NOUN
globalce-210	78	17	documents	document	NOUN
globalce-210	78	18	the	the	DET
globalce-210	78	19	document	document	NOUN
globalce-210	78	20	titled	title	VERB
globalce-210	78	21	“	"	PUNCT
globalce-210	78	22	proposed	propose	VERB
globalce-210	78	23	regulatory	regulatory	ADJ
globalce-210	78	24	framework	framework	NOUN
globalce-210	78	25	for	for	ADP
globalce-210	78	26	modifications	modification	NOUN
globalce-210	78	27	to	to	PART
globalce-210	78	28	ai	ai	VERB
globalce-210	78	29	/	/	SYM
globalce-210	78	30	ml	ml	NOUN
globalce-210	78	31	-	-	PUNCT
globalce-210	78	32	based	base	VERB
globalce-210	78	33	software	software	NOUN
globalce-210	78	34	as	as	ADP
globalce-210	78	35	a	a	DET
globalce-210	78	36	medical	medical	ADJ
globalce-210	78	37	device	device	NOUN
globalce-210	78	38	”	"	PUNCT
globalce-210	78	39	published	publish	VERB
globalce-210	78	40	in	in	ADP
globalce-210	78	41	april	april	PROPN
globalce-210	78	42	2019	2019	NUM
globalce-210	78	43	explores	explore	VERB
globalce-210	78	44	a	a	DET
globalce-210	78	45	potential	potential	ADJ
globalce-210	78	46	method	method	NOUN
globalce-210	78	47	for	for	ADP
globalce-210	78	48	evaluating	evaluate	VERB
globalce-210	78	49	ai	ai	VERB
globalce-210	78	50	/	/	SYM
globalce-210	78	51	ml	ml	NOUN
globalce-210	78	52	modifications	modification	NOUN
globalce-210	78	53	before	before	SCONJ
globalce-210	78	54	they	they	PRON
globalce-210	78	55	are	be	AUX
globalce-210	78	56	released	release	VERB
globalce-210	78	57	to	to	ADP
globalce-210	78	58	the	the	DET
globalce-210	78	59	market	market	NOUN
globalce-210	78	60	.	.	PUNCT
globalce-210	79	1	in	in	ADP
globalce-210	79	2	january	january	PROPN
globalce-210	79	3	2021	2021	NUM
globalce-210	79	4	,	,	PUNCT
globalce-210	79	5	the	the	DET
globalce-210	79	6	fda	fda	PROPN
globalce-210	79	7	issued	issue	VERB
globalce-210	79	8	the	the	DET
globalce-210	79	9	“	"	PUNCT
globalce-210	79	10	ai	ai	NOUN
globalce-210	79	11	/	/	SYM
globalce-210	79	12	ml	ml	ADV
globalce-210	79	13	samd	samd	ADJ
globalce-210	79	14	action	action	NOUN
globalce-210	79	15	plan	plan	NOUN
globalce-210	79	16	”	"	PUNCT
globalce-210	79	17	,	,	PUNCT
globalce-210	79	18	which	which	PRON
globalce-210	79	19	offers	offer	VERB
globalce-210	79	20	a	a	DET
globalce-210	79	21	comprehensive	comprehensive	ADJ
globalce-210	79	22	framework	framework	NOUN
globalce-210	79	23	for	for	ADP
globalce-210	79	24	regulating	regulate	VERB
globalce-210	79	25	ai	ai	NOUN
globalce-210	79	26	and	and	CCONJ
globalce-210	79	27	ml	ml	ADP
globalce-210	79	28	technologies	technology	NOUN
globalce-210	79	29	in	in	ADP
globalce-210	79	30	samd.27	samd.27	PROPN
globalce-210	79	31	the	the	DET
globalce-210	79	32	title	title	NOUN
globalce-210	79	33	of	of	ADP
globalce-210	79	34	the	the	DET
globalce-210	79	35	event	event	NOUN
globalce-210	79	36	in	in	ADP
globalce-210	79	37	october	october	PROPN
globalce-210	79	38	2021	2021	NUM
globalce-210	79	39	was	be	AUX
globalce-210	79	40	“	"	PUNCT
globalce-210	79	41	good	good	ADJ
globalce-210	79	42	machine	machine	NOUN
globalce-210	79	43	learning	learning	NOUN
globalce-210	79	44	practice	practice	NOUN
globalce-210	79	45	for	for	ADP
globalce-210	79	46	medical	medical	ADJ
globalce-210	79	47	device	device	NOUN
globalce-210	79	48	development	development	NOUN
globalce-210	79	49	:	:	PUNCT
globalce-210	79	50	guiding	guide	VERB
globalce-210	79	51	principles	principle	NOUN
globalce-210	79	52	”	"	PUNCT
globalce-210	79	53	.	.	PUNCT
globalce-210	80	1	in	in	ADP
globalce-210	80	2	april	april	PROPN
globalce-210	80	3	2023	2023	NUM
globalce-210	80	4	,	,	PUNCT
globalce-210	80	5	draft	draft	NOUN
globalce-210	80	6	guidance	guidance	NOUN
globalce-210	80	7	was	be	AUX
globalce-210	80	8	released	release	VERB
globalce-210	80	9	on	on	ADP
globalce-210	80	10	“	"	PUNCT
globalce-210	80	11	marketing	marketing	NOUN
globalce-210	80	12	submission	submission	NOUN
globalce-210	80	13	recommendations	recommendation	NOUN
globalce-210	80	14	for	for	ADP
globalce-210	80	15	a	a	DET
globalce-210	80	16	predetermined	predetermine	VERB
globalce-210	80	17	change	change	NOUN
globalce-210	80	18	control	control	NOUN
globalce-210	80	19	plan	plan	NOUN
globalce-210	80	20	for	for	ADP
globalce-210	80	21	ai	ai	VERB
globalce-210	80	22	/	/	SYM
globalce-210	80	23	ml	ml	VERB
globalce-210	80	24	-	-	PUNCT
globalce-210	80	25	enabled	enable	VERB
globalce-210	80	26	device	device	NOUN
globalce-210	80	27	software	software	NOUN
globalce-210	80	28	functions	function	NOUN
globalce-210	80	29	.	.	PUNCT
globalce-210	81	1	”28	”28	VERB
globalce-210	81	2	the	the	DET
globalce-210	81	3	title	title	NOUN
globalce-210	81	4	of	of	ADP
globalce-210	81	5	the	the	DET
globalce-210	81	6	publication	publication	NOUN
globalce-210	81	7	in	in	ADP
globalce-210	81	8	october	october	PROPN
globalce-210	81	9	2023	2023	NUM
globalce-210	81	10	was	be	AUX
globalce-210	81	11	“	"	PUNCT
globalce-210	81	12	guiding	guide	VERB
globalce-210	81	13	principles	principle	NOUN
globalce-210	81	14	for	for	ADP
globalce-210	81	15	predetermined	predetermine	VERB
globalce-210	81	16	change	change	NOUN
globalce-210	81	17	control	control	NOUN
globalce-210	81	18	plans	plan	NOUN
globalce-210	81	19	in	in	ADP
globalce-210	81	20	machine	machine	NOUN
globalce-210	81	21	learning	learning	NOUN
globalce-210	81	22	-	-	PUNCT
globalce-210	81	23	enabled	enable	VERB
globalce-210	81	24	medical	medical	ADJ
globalce-210	81	25	devices	device	NOUN
globalce-210	81	26	.	.	PUNCT
globalce-210	81	27	”	"	PUNCT
globalce-210	82	1	the	the	DET
globalce-210	82	2	title	title	NOUN
globalce-210	82	3	of	of	ADP
globalce-210	82	4	the	the	DET
globalce-210	82	5	publication	publication	NOUN
globalce-210	82	6	released	release	VERB
globalce-210	82	7	in	in	ADP
globalce-210	82	8	june	june	PROPN
globalce-210	82	9	2024	2024	NUM
globalce-210	82	10	was	be	AUX
globalce-210	82	11	gaur	gaur	NOUN
globalce-210	82	12	,	,	PUNCT
globalce-210	82	13	akram	akram	PROPN
globalce-210	82	14	,	,	PUNCT
globalce-210	82	15	singh	singh	PROPN
globalce-210	82	16	,	,	PUNCT
globalce-210	82	17	chauhan	chauhan	PROPN
globalce-210	82	18	:	:	PUNCT
globalce-210	82	19	artificial	artificial	ADJ
globalce-210	82	20	intelligence	intelligence	NOUN
globalce-210	82	21	-	-	PUNCT
globalce-210	82	22	driven	drive	VERB
globalce-210	82	23	insights	insight	NOUN
globalce-210	82	24	for	for	ADP
globalce-210	82	25	regulatory	regulatory	ADJ
globalce-210	82	26	intelligence	intelligence	NOUN
globalce-210	82	27	in	in	ADP
globalce-210	82	28	medical	medical	ADJ
globalce-210	82	29	devices	device	NOUN
globalce-210	82	30	:	:	PUNCT
globalce-210	82	31	evaluating	evaluate	VERB
globalce-210	82	32	ema	ema	PROPN
globalce-210	82	33	,	,	PUNCT
globalce-210	82	34	fda	fda	PROPN
globalce-210	82	35	,	,	PUNCT
globalce-210	82	36	and	and	CCONJ
globalce-210	82	37	cdsco	cdsco	PROPN
globalce-210	82	38	frameworks	framework	VERB
globalce-210	82	39	j	j	PROPN
globalce-210	82	40	global	global	ADJ
globalce-210	82	41	clinical	clinical	ADJ
globalce-210	82	42	engineering	engineering	NOUN
globalce-210	82	43	vol.7	vol.7	PROPN
globalce-210	82	44	issue	issue	NOUN
globalce-210	82	45	2	2	NUM
globalce-210	82	46	:	:	SYM
globalce-210	82	47	2025	2025	NUM
globalce-210	82	48	16	16	NUM
globalce-210	82	49	“	"	PUNCT
globalce-210	82	50	transparency	transparency	NOUN
globalce-210	82	51	for	for	ADP
globalce-210	82	52	machine	machine	NOUN
globalce-210	82	53	learning	learning	NOUN
globalce-210	82	54	-	-	PUNCT
globalce-210	82	55	enabled	enable	VERB
globalce-210	82	56	medical	medical	ADJ
globalce-210	82	57	devices	device	NOUN
globalce-210	82	58	:	:	PUNCT
globalce-210	82	59	guiding	guide	VERB
globalce-210	82	60	principles	principle	NOUN
globalce-210	82	61	.	.	PUNCT
globalce-210	82	62	”	"	PUNCT
globalce-210	83	1	29	29	NUM
globalce-210	83	2	fda	fda	PROPN
globalce-210	83	3	guidelines	guideline	NOUN
globalce-210	83	4	for	for	ADP
globalce-210	83	5	ai	ai	NOUN
globalce-210	83	6	/	/	SYM
globalce-210	83	7	ml	ml	NOUN
globalce-210	83	8	-	-	PUNCT
globalce-210	83	9	based	base	VERB
globalce-210	83	10	software	software	NOUN
globalce-210	83	11	as	as	ADP
globalce-210	83	12	a	a	DET
globalce-210	83	13	medical	medical	ADJ
globalce-210	83	14	device	device	NOUN
globalce-210	83	15	the	the	DET
globalce-210	83	16	fda	fda	PROPN
globalce-210	83	17	’s	’s	PART
globalce-210	83	18	total	total	ADJ
globalce-210	83	19	product	product	NOUN
globalce-210	83	20	lifecycle	lifecycle	NOUN
globalce-210	83	21	(	(	PUNCT
globalce-210	83	22	tplc	tplc	NOUN
globalce-210	83	23	)	)	PUNCT
globalce-210	83	24	approach	approach	NOUN
globalce-210	83	25	to	to	ADP
globalce-210	83	26	regulation	regulation	NOUN
globalce-210	83	27	aims	aim	VERB
globalce-210	83	28	to	to	PART
globalce-210	83	29	expedite	expedite	VERB
globalce-210	83	30	the	the	DET
globalce-210	83	31	enhancement	enhancement	NOUN
globalce-210	83	32	process	process	NOUN
globalce-210	83	33	of	of	ADP
globalce-210	83	34	samd	samd	NOUN
globalce-210	83	35	utilizing	utilize	VERB
globalce-210	83	36	ai	ai	VERB
globalce-210	83	37	and	and	CCONJ
globalce-210	83	38	ml	ml	NOUN
globalce-210	83	39	,	,	PUNCT
globalce-210	83	40	while	while	SCONJ
globalce-210	83	41	ensuring	ensure	VERB
globalce-210	83	42	compliance	compliance	NOUN
globalce-210	83	43	with	with	ADP
globalce-210	83	44	all	all	DET
globalce-210	83	45	essential	essential	ADJ
globalce-210	83	46	safety	safety	NOUN
globalce-210	83	47	protocols	protocol	NOUN
globalce-210	83	48	.	.	PUNCT
globalce-210	84	1	developers	developer	NOUN
globalce-210	84	2	are	be	AUX
globalce-210	84	3	anticipated	anticipate	VERB
globalce-210	84	4	to	to	PART
globalce-210	84	5	be	be	AUX
globalce-210	84	6	transparent	transparent	ADJ
globalce-210	84	7	about	about	ADP
globalce-210	84	8	the	the	DET
globalce-210	84	9	functionality	functionality	NOUN
globalce-210	84	10	of	of	ADP
globalce-210	84	11	their	their	PRON
globalce-210	84	12	products	product	NOUN
globalce-210	84	13	in	in	ADP
globalce-210	84	14	real	real	ADJ
globalce-210	84	15	-	-	PUNCT
globalce-210	84	16	world	world	NOUN
globalce-210	84	17	scenarios	scenario	NOUN
globalce-210	84	18	and	and	CCONJ
globalce-210	84	19	adhere	adhere	VERB
globalce-210	84	20	to	to	ADP
globalce-210	84	21	both	both	CCONJ
globalce-210	84	22	good	good	ADJ
globalce-210	84	23	ml	ml	NOUN
globalce-210	84	24	practices	practice	NOUN
globalce-210	84	25	(	(	PUNCT
globalce-210	84	26	gmlp	gmlp	VERB
globalce-210	84	27	)	)	PUNCT
globalce-210	84	28	and	and	CCONJ
globalce-210	84	29	quality	quality	NOUN
globalce-210	84	30	systems	system	NOUN
globalce-210	84	31	.	.	PUNCT
globalce-210	85	1	the	the	DET
globalce-210	85	2	tplc	tplc	PROPN
globalce-210	85	3	framework	framework	NOUN
globalce-210	85	4	enables	enable	VERB
globalce-210	85	5	manufacturers	manufacturer	NOUN
globalce-210	85	6	to	to	PART
globalce-210	85	7	present	present	VERB
globalce-210	85	8	change	change	NOUN
globalce-210	85	9	control	control	NOUN
globalce-210	85	10	plans	plan	NOUN
globalce-210	85	11	that	that	PRON
globalce-210	85	12	have	have	AUX
globalce-210	85	13	been	be	AUX
globalce-210	85	14	implemented	implement	VERB
globalce-210	85	15	prior	prior	ADV
globalce-210	85	16	to	to	ADP
globalce-210	85	17	the	the	DET
globalce-210	85	18	initial	initial	ADJ
globalce-210	85	19	premarket	premarket	NOUN
globalce-210	85	20	review	review	NOUN
globalce-210	85	21	process.30	process.30	VERB
globalce-210	85	22	this	this	PRON
globalce-210	85	23	allows	allow	VERB
globalce-210	85	24	for	for	ADP
globalce-210	85	25	specific	specific	ADJ
globalce-210	85	26	modifications	modification	NOUN
globalce-210	85	27	to	to	PART
globalce-210	85	28	be	be	AUX
globalce-210	85	29	implemented	implement	VERB
globalce-210	85	30	without	without	ADP
globalce-210	85	31	necessitating	necessitate	VERB
globalce-210	85	32	a	a	DET
globalce-210	85	33	fresh	fresh	ADJ
globalce-210	85	34	evaluation	evaluation	NOUN
globalce-210	85	35	process	process	NOUN
globalce-210	85	36	.	.	PUNCT
globalce-210	86	1	the	the	DET
globalce-210	86	2	fda	fda	PROPN
globalce-210	86	3	granted	grant	VERB
globalce-210	86	4	approval	approval	NOUN
globalce-210	86	5	up	up	ADP
globalce-210	86	6	to	to	ADP
globalce-210	86	7	2024	2024	NUM
globalce-210	86	8	to	to	ADP
globalce-210	86	9	approximately	approximately	ADV
globalce-210	86	10	64	64	NUM
globalce-210	86	11	medical	medical	ADJ
globalce-210	86	12	devices	device	NOUN
globalce-210	86	13	that	that	PRON
globalce-210	86	14	utilize	utilize	VERB
globalce-210	86	15	ai	ai	ADP
globalce-210	86	16	and	and	CCONJ
globalce-210	86	17	ml	ml	CCONJ
globalce-210	86	18	,	,	PUNCT
globalce-210	86	19	with	with	ADP
globalce-210	86	20	the	the	DET
globalce-210	86	21	majority	majority	NOUN
globalce-210	86	22	being	be	AUX
globalce-210	86	23	approved	approve	VERB
globalce-210	86	24	through	through	ADP
globalce-210	86	25	the	the	DET
globalce-210	86	26	510(k	510(k	PROPN
globalce-210	86	27	)	)	PUNCT
globalce-210	86	28	pathway	pathway	NOUN
globalce-210	86	29	.	.	PUNCT
globalce-210	87	1	the	the	DET
globalce-210	87	2	agency	agency	NOUN
globalce-210	87	3	is	be	AUX
globalce-210	87	4	currently	currently	ADV
globalce-210	87	5	endeavoring	endeavor	VERB
globalce-210	87	6	to	to	PART
globalce-210	87	7	enhance	enhance	VERB
globalce-210	87	8	its	its	PRON
globalce-210	87	9	regulatory	regulatory	ADJ
globalce-210	87	10	framework	framework	NOUN
globalce-210	87	11	in	in	ADP
globalce-210	87	12	order	order	NOUN
globalce-210	87	13	to	to	PART
globalce-210	87	14	match	match	VERB
globalce-210	87	15	the	the	DET
globalce-210	87	16	rapid	rapid	ADJ
globalce-210	87	17	pace	pace	NOUN
globalce-210	87	18	at	at	ADP
globalce-210	87	19	which	which	PRON
globalce-210	87	20	these	these	DET
globalce-210	87	21	technologies	technology	NOUN
globalce-210	87	22	are	be	AUX
globalce-210	87	23	evolving.31	evolving.31	VERB
globalce-210	87	24	the	the	DET
globalce-210	87	25	recommendations	recommendation	NOUN
globalce-210	87	26	from	from	ADP
globalce-210	87	27	the	the	DET
globalce-210	87	28	guidelines	guideline	NOUN
globalce-210	87	29	:	:	PUNCT
globalce-210	87	30	the	the	DET
globalce-210	87	31	fda	fda	PROPN
globalce-210	87	32	’s	’s	PART
globalce-210	87	33	guidelines	guideline	NOUN
globalce-210	87	34	on	on	ADP
globalce-210	87	35	ai	ai	NOUN
globalce-210	87	36	/	/	SYM
globalce-210	87	37	ml	ml	VERB
globalce-210	87	38	-	-	PUNCT
globalce-210	87	39	based	base	VERB
globalce-210	87	40	samd	samd	NOUN
globalce-210	87	41	are	be	AUX
globalce-210	87	42	classified	classify	VERB
globalce-210	87	43	into	into	ADP
globalce-210	87	44	three	three	NUM
globalce-210	87	45	broad	broad	ADJ
globalce-210	87	46	categories	category	NOUN
globalce-210	87	47	,	,	PUNCT
globalce-210	87	48	i.e.	i.e.	X
globalce-210	87	49	,	,	PUNCT
globalce-210	87	50	assuring	assure	VERB
globalce-210	87	51	the	the	DET
globalce-210	87	52	safety	safety	NOUN
globalce-210	87	53	and	and	CCONJ
globalce-210	87	54	effectiveness	effectiveness	NOUN
globalce-210	87	55	of	of	ADP
globalce-210	87	56	these	these	DET
globalce-210	87	57	devices	device	NOUN
globalce-210	87	58	,	,	PUNCT
globalce-210	87	59	promoting	promote	VERB
globalce-210	87	60	good	good	ADJ
globalce-210	87	61	ml	ml	NOUN
globalce-210	87	62	practices	practice	NOUN
globalce-210	87	63	in	in	ADP
globalce-210	87	64	device	device	NOUN
globalce-210	87	65	development	development	NOUN
globalce-210	87	66	,	,	PUNCT
globalce-210	87	67	and	and	CCONJ
globalce-210	87	68	ensuring	ensure	VERB
globalce-210	87	69	transparency	transparency	NOUN
globalce-210	87	70	about	about	ADP
globalce-210	87	71	how	how	SCONJ
globalce-210	87	72	algorithms	algorithm	NOUN
globalce-210	87	73	reach	reach	VERB
globalce-210	87	74	their	their	PRON
globalce-210	87	75	outputs.32	outputs.32	NOUN
globalce-210	87	76	most	most	ADV
globalce-210	87	77	important	important	ADJ
globalce-210	87	78	suggestions	suggestion	NOUN
globalce-210	87	79	are	be	AUX
globalce-210	87	80	as	as	SCONJ
globalce-210	87	81	follows	follow	VERB
globalce-210	87	82	:	:	PUNCT
globalce-210	87	83	thorough	thorough	ADJ
globalce-210	87	84	validation	validation	NOUN
globalce-210	87	85	:	:	PUNCT
globalce-210	87	86	ai	ai	VERB
globalce-210	87	87	and	and	CCONJ
globalce-210	87	88	ml	ml	ADP
globalce-210	87	89	algorithms	algorithm	NOUN
globalce-210	87	90	need	need	VERB
globalce-210	87	91	to	to	PART
globalce-210	87	92	be	be	AUX
globalce-210	87	93	thoroughly	thoroughly	ADV
globalce-210	87	94	validated	validate	VERB
globalce-210	87	95	to	to	PART
globalce-210	87	96	show	show	VERB
globalce-210	87	97	that	that	SCONJ
globalce-210	87	98	they	they	PRON
globalce-210	87	99	work	work	VERB
globalce-210	87	100	as	as	ADP
globalce-210	87	101	intended	intend	VERB
globalce-210	87	102	and	and	CCONJ
globalce-210	87	103	give	give	VERB
globalce-210	87	104	correct	correct	ADJ
globalce-210	87	105	results	result	NOUN
globalce-210	87	106	.	.	PUNCT
globalce-210	88	1	this	this	PRON
globalce-210	88	2	would	would	AUX
globalce-210	88	3	include	include	VERB
globalce-210	88	4	clinical	clinical	ADJ
globalce-210	88	5	trials	trial	NOUN
globalce-210	88	6	and	and	CCONJ
globalce-210	88	7	tests	test	NOUN
globalce-210	88	8	against	against	ADP
globalce-210	88	9	well	well	ADV
globalce-210	88	10	-	-	PUNCT
globalce-210	88	11	known	know	VERB
globalce-210	88	12	ways	way	NOUN
globalce-210	88	13	of	of	ADP
globalce-210	88	14	diagnosing	diagnosing	NOUN
globalce-210	88	15	.	.	PUNCT
globalce-210	89	1	risk	risk	NOUN
globalce-210	89	2	management	management	NOUN
globalce-210	89	3	:	:	PUNCT
globalce-210	89	4	companies	company	NOUN
globalce-210	89	5	that	that	PRON
globalce-210	89	6	create	create	VERB
globalce-210	89	7	ai	ai	VERB
globalce-210	89	8	/	/	SYM
globalce-210	89	9	ml	ml	NOUN
globalce-210	89	10	algorithms	algorithm	NOUN
globalce-210	89	11	are	be	AUX
globalce-210	89	12	to	to	PART
globalce-210	89	13	search	search	VERB
globalce-210	89	14	for	for	ADP
globalce-210	89	15	and	and	CCONJ
globalce-210	89	16	mitigate	mitigate	VERB
globalce-210	89	17	any	any	DET
globalce-210	89	18	risks	risk	NOUN
globalce-210	89	19	associated	associate	VERB
globalce-210	89	20	with	with	ADP
globalce-210	89	21	it	it	PRON
globalce-210	89	22	.	.	PUNCT
globalce-210	90	1	biases	bias	NOUN
globalce-210	90	2	in	in	ADP
globalce-210	90	3	the	the	DET
globalce-210	90	4	data	datum	NOUN
globalce-210	90	5	used	use	VERB
globalce-210	90	6	to	to	PART
globalce-210	90	7	train	train	VERB
globalce-210	90	8	an	an	DET
globalce-210	90	9	algorithm	algorithm	NOUN
globalce-210	90	10	,	,	PUNCT
globalce-210	90	11	errors	error	NOUN
globalce-210	90	12	made	make	VERB
globalce-210	90	13	by	by	ADP
globalce-210	90	14	the	the	DET
globalce-210	90	15	algorithm	algorithm	NOUN
globalce-210	90	16	itself	itself	PRON
globalce-210	90	17	,	,	PUNCT
globalce-210	90	18	and	and	CCONJ
globalce-210	90	19	security	security	NOUN
globalce-210	90	20	vulnerabilities	vulnerability	NOUN
globalce-210	90	21	are	be	AUX
globalce-210	90	22	all	all	PRON
globalce-210	90	23	potential	potential	ADJ
globalce-210	90	24	problems.24	problems.24	ADJ
globalce-210	90	25	real	real	ADJ
globalce-210	90	26	-	-	PUNCT
globalce-210	90	27	world	world	NOUN
globalce-210	90	28	performance	performance	NOUN
globalce-210	90	29	monitoring	monitoring	NOUN
globalce-210	90	30	:	:	PUNCT
globalce-210	90	31	ai	ai	VERB
globalce-210	90	32	and	and	CCONJ
globalce-210	90	33	ml	ml	ADP
globalce-210	90	34	models	model	NOUN
globalce-210	90	35	can	can	AUX
globalce-210	90	36	learn	learn	VERB
globalce-210	90	37	from	from	ADP
globalce-210	90	38	experience	experience	NOUN
globalce-210	90	39	to	to	PART
globalce-210	90	40	improve	improve	VERB
globalce-210	90	41	performance	performance	NOUN
globalce-210	90	42	over	over	ADP
globalce-210	90	43	time	time	NOUN
globalce-210	90	44	,	,	PUNCT
globalce-210	90	45	so	so	ADV
globalce-210	90	46	the	the	DET
globalce-210	90	47	fda	fda	PROPN
globalce-210	90	48	recommends	recommend	VERB
globalce-210	90	49	using	use	VERB
globalce-210	90	50	real	real	ADJ
globalce-210	90	51	-	-	PUNCT
globalce-210	90	52	world	world	NOUN
globalce-210	90	53	clinical	clinical	ADJ
globalce-210	90	54	data	datum	NOUN
globalce-210	90	55	to	to	PART
globalce-210	90	56	continually	continually	ADV
globalce-210	90	57	assess	assess	VERB
globalce-210	90	58	a	a	DET
globalce-210	90	59	device	device	NOUN
globalce-210	90	60	’s	’s	PART
globalce-210	90	61	safety	safety	NOUN
globalce-210	90	62	and	and	CCONJ
globalce-210	90	63	effectiveness	effectiveness	NOUN
globalce-210	90	64	.	.	PUNCT
globalce-210	91	1	good	good	ADJ
globalce-210	91	2	machine	machine	NOUN
globalce-210	91	3	learning	learning	NOUN
globalce-210	91	4	practices	practice	NOUN
globalce-210	91	5	:	:	PUNCT
globalce-210	91	6	according	accord	VERB
globalce-210	91	7	to	to	ADP
globalce-210	91	8	the	the	DET
globalce-210	91	9	fda	fda	PROPN
globalce-210	91	10	,	,	PUNCT
globalce-210	91	11	gmlp	gmlp	PROPN
globalce-210	91	12	refers	refer	VERB
globalce-210	91	13	to	to	ADP
globalce-210	91	14	following	follow	VERB
globalce-210	91	15	the	the	DET
globalce-210	91	16	ml	ml	PROPN
globalce-210	91	17	development	development	NOUN
globalce-210	91	18	best	good	ADJ
globalce-210	91	19	practices	practice	NOUN
globalce-210	91	20	throughout	throughout	ADP
globalce-210	91	21	the	the	DET
globalce-210	91	22	entire	entire	ADJ
globalce-210	91	23	ml	ml	NOUN
globalce-210	91	24	lifecycle	lifecycle	NOUN
globalce-210	91	25	.	.	PUNCT
globalce-210	92	1	if	if	SCONJ
globalce-210	92	2	you	you	PRON
globalce-210	92	3	follow	follow	VERB
globalce-210	92	4	a	a	DET
globalce-210	92	5	best	good	ADJ
globalce-210	92	6	practices	practice	NOUN
globalce-210	92	7	process	process	NOUN
globalce-210	92	8	,	,	PUNCT
globalce-210	92	9	such	such	ADJ
globalce-210	92	10	as	as	ADP
globalce-210	92	11	training	training	NOUN
globalce-210	92	12	with	with	ADP
globalce-210	92	13	great	great	ADJ
globalce-210	92	14	real	real	ADJ
globalce-210	92	15	-	-	PUNCT
globalce-210	92	16	world	world	NOUN
globalce-210	92	17	data	datum	NOUN
globalce-210	92	18	,	,	PUNCT
globalce-210	92	19	keeping	keep	VERB
globalce-210	92	20	good	good	ADJ
globalce-210	92	21	model	model	NOUN
globalce-210	92	22	development	development	NOUN
globalce-210	92	23	and	and	CCONJ
globalce-210	92	24	validation	validation	NOUN
globalce-210	92	25	practices	practice	NOUN
globalce-210	92	26	,	,	PUNCT
globalce-210	92	27	or	or	CCONJ
globalce-210	92	28	making	make	VERB
globalce-210	92	29	sure	sure	ADJ
globalce-210	92	30	the	the	DET
globalce-210	92	31	software	software	NOUN
globalce-210	92	32	has	have	AUX
globalce-210	92	33	strong	strong	ADJ
globalce-210	92	34	versioning	versione	VERB
globalce-210	92	35	support.33	support.33	NOUN
globalce-210	92	36	predetermined	predetermine	VERB
globalce-210	92	37	change	change	NOUN
globalce-210	92	38	control	control	NOUN
globalce-210	92	39	plans	plan	NOUN
globalce-210	92	40	(	(	PUNCT
globalce-210	92	41	pccp	pccp	PROPN
globalce-210	92	42	):	):	PUNCT
globalce-210	92	43	the	the	DET
globalce-210	92	44	ai	ai	NOUN
globalce-210	92	45	/	/	SYM
globalce-210	92	46	ml	ml	NOUN
globalce-210	92	47	model	model	NOUN
globalce-210	92	48	should	should	AUX
globalce-210	92	49	learn	learn	VERB
globalce-210	92	50	and	and	CCONJ
globalce-210	92	51	change	change	VERB
globalce-210	92	52	over	over	ADP
globalce-210	92	53	time	time	NOUN
globalce-210	92	54	,	,	PUNCT
globalce-210	92	55	so	so	SCONJ
globalce-210	92	56	manufacturers	manufacturer	NOUN
globalce-210	92	57	should	should	AUX
globalce-210	92	58	set	set	VERB
globalce-210	92	59	up	up	ADP
globalce-210	92	60	a	a	DET
globalce-210	92	61	pccp	pccp	NOUN
globalce-210	92	62	that	that	PRON
globalce-210	92	63	explains	explain	VERB
globalce-210	92	64	how	how	SCONJ
globalce-210	92	65	it	it	PRON
globalce-210	92	66	will	will	AUX
globalce-210	92	67	do	do	VERB
globalce-210	92	68	this	this	PRON
globalce-210	92	69	.	.	PUNCT
globalce-210	93	1	the	the	DET
globalce-210	93	2	pccp	pccp	PROPN
globalce-210	93	3	should	should	AUX
globalce-210	93	4	have	have	VERB
globalce-210	93	5	steps	step	NOUN
globalce-210	93	6	for	for	ADP
globalce-210	93	7	finding	finding	NOUN
globalce-210	93	8	,	,	PUNCT
globalce-210	93	9	evaluating	evaluating	NOUN
globalce-210	93	10	,	,	PUNCT
globalce-210	93	11	and	and	CCONJ
globalce-210	93	12	lowering	lower	VERB
globalce-210	93	13	the	the	DET
globalce-210	93	14	risks	risk	NOUN
globalce-210	93	15	that	that	PRON
globalce-210	93	16	might	might	AUX
globalce-210	93	17	come	come	VERB
globalce-210	93	18	with	with	ADP
globalce-210	93	19	changing	change	VERB
globalce-210	93	20	algorithms.34	algorithms.34	NOUN
globalce-210	93	21	clear	clear	ADJ
globalce-210	93	22	user	user	NOUN
globalce-210	93	23	manuals	manual	NOUN
globalce-210	93	24	:	:	PUNCT
globalce-210	93	25	the	the	DET
globalce-210	93	26	samd	samd	NOUN
globalce-210	93	27	should	should	AUX
globalce-210	93	28	come	come	VERB
globalce-210	93	29	with	with	ADP
globalce-210	93	30	clear	clear	ADJ
globalce-210	93	31	and	and	CCONJ
globalce-210	93	32	detailed	detailed	ADJ
globalce-210	93	33	user	user	NOUN
globalce-210	93	34	manuals	manual	NOUN
globalce-210	93	35	that	that	PRON
globalce-210	93	36	explain	explain	VERB
globalce-210	93	37	what	what	PRON
globalce-210	93	38	the	the	DET
globalce-210	93	39	device	device	NOUN
globalce-210	93	40	can	can	AUX
globalce-210	93	41	and	and	CCONJ
globalce-210	93	42	ca	can	AUX
globalce-210	93	43	n't	not	PART
globalce-210	93	44	do	do	VERB
globalce-210	93	45	and	and	CCONJ
globalce-210	93	46	how	how	SCONJ
globalce-210	93	47	the	the	DET
globalce-210	93	48	ai	ai	NOUN
globalce-210	93	49	/	/	SYM
globalce-210	93	50	ml	ml	NOUN
globalce-210	93	51	algorithms	algorithms	NOUN
globalce-210	93	52	work	work	VERB
globalce-210	93	53	.	.	PUNCT
globalce-210	94	1	data	datum	NOUN
globalce-210	94	2	transparency	transparency	NOUN
globalce-210	94	3	:	:	PUNCT
globalce-210	94	4	users	user	NOUN
globalce-210	94	5	should	should	AUX
globalce-210	94	6	know	know	VERB
globalce-210	94	7	what	what	PRON
globalce-210	94	8	kind	kind	NOUN
globalce-210	94	9	of	of	ADP
globalce-210	94	10	data	datum	NOUN
globalce-210	94	11	were	be	AUX
globalce-210	94	12	used	use	VERB
globalce-210	94	13	to	to	PART
globalce-210	94	14	train	train	VERB
globalce-210	94	15	ai	ai	VERB
globalce-210	94	16	/	/	SYM
globalce-210	94	17	ml	ml	NOUN
globalce-210	94	18	models	model	NOUN
globalce-210	94	19	and	and	CCONJ
globalce-210	94	20	if	if	SCONJ
globalce-210	94	21	there	there	PRON
globalce-210	94	22	are	be	VERB
globalce-210	94	23	any	any	DET
globalce-210	94	24	biases	bias	NOUN
globalce-210	94	25	that	that	PRON
globalce-210	94	26	could	could	AUX
globalce-210	94	27	affect	affect	VERB
globalce-210	94	28	the	the	DET
globalce-210	94	29	outputs	output	NOUN
globalce-210	94	30	of	of	ADP
globalce-210	94	31	the	the	DET
globalce-210	94	32	device	device	NOUN
globalce-210	94	33	.	.	PUNCT
globalce-210	95	1	transparency	transparency	NOUN
globalce-210	95	2	of	of	ADP
globalce-210	95	3	algorithmic	algorithmic	ADJ
globalce-210	95	4	functioning	functioning	NOUN
globalce-210	95	5	:	:	PUNCT
globalce-210	95	6	the	the	DET
globalce-210	95	7	level	level	NOUN
globalce-210	95	8	of	of	ADP
globalce-210	95	9	details	detail	NOUN
globalce-210	95	10	about	about	ADP
globalce-210	95	11	how	how	SCONJ
globalce-210	95	12	the	the	DET
globalce-210	95	13	ai	ai	NOUN
globalce-210	95	14	/	/	SYM
globalce-210	95	15	ml	ml	NOUN
globalce-210	95	16	algorithms	algorithm	NOUN
globalce-210	95	17	work	work	VERB
globalce-210	95	18	on	on	ADP
globalce-210	95	19	the	the	DET
globalce-210	95	20	inside	inside	NOUN
globalce-210	95	21	may	may	AUX
globalce-210	95	22	change	change	VERB
globalce-210	95	23	depending	depend	VERB
globalce-210	95	24	on	on	ADP
globalce-210	95	25	how	how	SCONJ
globalce-210	95	26	complicated	complicated	ADJ
globalce-210	95	27	is	be	AUX
globalce-210	95	28	the	the	DET
globalce-210	95	29	device.35	device.35	ADJ
globalce-210	95	30	fda	fda	PROPN
globalce-210	95	31	’s	’s	PART
globalce-210	95	32	regulatory	regulatory	ADJ
globalce-210	95	33	approach	approach	NOUN
globalce-210	95	34	for	for	ADP
globalce-210	95	35	adaptive	adaptive	ADJ
globalce-210	95	36	ai	ai	ADJ
globalce-210	95	37	-	-	PUNCT
globalce-210	95	38	driven	drive	VERB
globalce-210	95	39	devices	device	NOUN
globalce-210	95	40	while	while	SCONJ
globalce-210	95	41	the	the	DET
globalce-210	95	42	fda	fda	PROPN
globalce-210	95	43	recognized	recognize	VERB
globalce-210	95	44	that	that	SCONJ
globalce-210	95	45	ai	ai	VERB
globalce-210	95	46	and	and	CCONJ
globalce-210	95	47	ml	ml	VERB
globalce-210	95	48	may	may	AUX
globalce-210	95	49	now	now	ADV
globalce-210	95	50	be	be	AUX
globalce-210	95	51	transformative	transformative	ADJ
globalce-210	95	52	in	in	ADP
globalce-210	95	53	medical	medical	ADJ
globalce-210	95	54	devices	device	NOUN
globalce-210	95	55	,	,	PUNCT
globalce-210	95	56	it	it	PRON
globalce-210	95	57	also	also	ADV
globalce-210	95	58	recognizes	recognize	VERB
globalce-210	95	59	that	that	SCONJ
globalce-210	95	60	its	its	PRON
globalce-210	95	61	traditional	traditional	ADJ
globalce-210	95	62	regulatory	regulatory	ADJ
globalce-210	95	63	framework	framework	NOUN
globalce-210	95	64	is	be	AUX
globalce-210	95	65	likely	likely	ADJ
globalce-210	95	66	not	not	PART
globalce-210	95	67	well	well	ADV
globalce-210	95	68	suited	suited	ADJ
globalce-210	95	69	for	for	ADP
globalce-210	95	70	these	these	DET
globalce-210	95	71	ever	ever	ADV
globalce-210	95	72	-	-	PUNCT
globalce-210	95	73	evolving	evolve	VERB
globalce-210	95	74	techs	tech	NOUN
globalce-210	95	75	.	.	PUNCT
globalce-210	96	1	in	in	ADP
globalce-210	96	2	response	response	NOUN
globalce-210	96	3	,	,	PUNCT
globalce-210	96	4	the	the	DET
globalce-210	96	5	agency	agency	NOUN
globalce-210	96	6	launched	launch	VERB
globalce-210	96	7	a	a	DET
globalce-210	96	8	new	new	ADJ
globalce-210	96	9	tplc	tplc	NOUN
globalce-210	96	10	initiative	initiative	NOUN
globalce-210	96	11	that	that	PRON
globalce-210	96	12	uses	use	VERB
globalce-210	96	13	existing	exist	VERB
globalce-210	96	14	premarket	premarket	NOUN
globalce-210	96	15	pathways	pathway	NOUN
globalce-210	96	16	in	in	ADP
globalce-210	96	17	combination	combination	NOUN
globalce-210	96	18	with	with	ADP
globalce-210	96	19	risk	risk	NOUN
globalce-210	96	20	management	management	NOUN
globalce-210	96	21	and	and	CCONJ
globalce-210	96	22	authorization	authorization	NOUN
globalce-210	96	23	from	from	ADP
globalce-210	96	24	its	its	PRON
globalce-210	96	25	pre	pre	ADJ
globalce-210	96	26	-	-	ADJ
globalce-210	96	27	cert	cert	ADJ
globalce-210	96	28	program	program	NOUN
globalce-210	96	29	.	.	PUNCT
globalce-210	97	1	nationwide	nationwide	ADJ
globalce-210	97	2	strategies	strategy	NOUN
globalce-210	97	3	mean	mean	VERB
globalce-210	97	4	to	to	PART
globalce-210	97	5	diminish	diminish	VERB
globalce-210	97	6	the	the	DET
globalce-210	97	7	obstructions	obstruction	NOUN
globalce-210	97	8	confronting	confront	VERB
globalce-210	97	9	programming	programming	NOUN
globalce-210	97	10	designers	designer	NOUN
globalce-210	97	11	and	and	CCONJ
globalce-210	97	12	other	other	ADJ
globalce-210	97	13	human	human	ADJ
globalce-210	97	14	service	service	NOUN
globalce-210	97	15	suppliers	supplier	NOUN
globalce-210	97	16	in	in	ADP
globalce-210	97	17	executing	execute	VERB
globalce-210	97	18	conduct	conduct	NOUN
globalce-210	97	19	of	of	ADP
globalce-210	97	20	science	science	NOUN
globalce-210	97	21	criticism	criticism	NOUN
globalce-210	97	22	;	;	PUNCT
globalce-210	97	23	simultaneously	simultaneously	ADV
globalce-210	97	24	,	,	PUNCT
globalce-210	97	25	direction	direction	NOUN
globalce-210	97	26	laid	lay	VERB
globalce-210	97	27	down	down	ADP
globalce-210	97	28	with	with	ADP
globalce-210	97	29	respect	respect	NOUN
globalce-210	97	30	to	to	ADP
globalce-210	97	31	a	a	DET
globalce-210	97	32	“	"	PUNCT
globalce-210	97	33	strict	strict	ADJ
globalce-210	97	34	control	control	NOUN
globalce-210	97	35	”	"	PUNCT
globalce-210	97	36	change	change	NOUN
globalce-210	97	37	for	for	ADP
globalce-210	97	38	guideline	guideline	NOUN
globalce-210	97	39	focus	focus	NOUN
globalce-210	97	40	on	on	ADP
globalce-210	97	41	ml	ml	NOUN
globalce-210	97	42	techniques.36	techniques.36	VERB
globalce-210	97	43	with	with	ADP
globalce-210	97	44	a	a	DET
globalce-210	97	45	large	large	ADJ
globalce-210	97	46	guide	guide	NOUN
globalce-210	97	47	that	that	PRON
globalce-210	97	48	provides	provide	VERB
globalce-210	97	49	transparency	transparency	NOUN
globalce-210	97	50	during	during	ADP
globalce-210	97	51	each	each	DET
globalce-210	97	52	step	step	NOUN
globalce-210	97	53	of	of	ADP
globalce-210	97	54	ai	ai	VERB
globalce-210	97	55	algorithms	algorithm	NOUN
globalce-210	97	56	suggested	suggest	VERB
globalce-210	97	57	by	by	ADP
globalce-210	97	58	the	the	DET
globalce-210	97	59	fda	fda	PROPN
globalce-210	97	60	,	,	PUNCT
globalce-210	97	61	this	this	PRON
globalce-210	97	62	can	can	AUX
globalce-210	97	63	help	help	VERB
globalce-210	97	64	you	you	PRON
globalce-210	97	65	make	make	VERB
globalce-210	97	66	the	the	DET
globalce-210	97	67	most	most	ADJ
globalce-210	97	68	out	out	ADP
globalce-210	97	69	of	of	ADP
globalce-210	97	70	developing	develop	VERB
globalce-210	97	71	tools	tool	NOUN
globalce-210	97	72	or	or	CCONJ
globalce-210	97	73	models	model	NOUN
globalce-210	97	74	with	with	ADP
globalce-210	97	75	features	feature	NOUN
globalce-210	97	76	-	-	PUNCT
globalce-210	97	77	proposed	propose	VERB
globalce-210	97	78	higher	high	ADJ
globalce-210	97	79	-	-	PUNCT
globalce-210	97	80	up	up	ADP
globalce-210	97	81	code	code	NOUN
globalce-210	97	82	.	.	PUNCT
globalce-210	98	1	two	two	NUM
globalce-210	98	2	components	component	NOUN
globalce-210	98	3	of	of	ADP
globalce-210	98	4	the	the	DET
globalce-210	98	5	tplc	tplc	NOUN
globalce-210	98	6	framework	framework	NOUN
globalce-210	98	7	,	,	PUNCT
globalce-210	98	8	however	however	ADV
globalce-210	98	9	,	,	PUNCT
globalce-210	98	10	probably	probably	ADV
globalce-210	98	11	would	would	AUX
globalce-210	98	12	require	require	VERB
globalce-210	98	13	more	more	ADJ
globalce-210	98	14	statutory	statutory	ADJ
globalce-210	98	15	authority	authority	NOUN
globalce-210	98	16	to	to	PART
globalce-210	98	17	fully	fully	ADV
globalce-210	98	18	implement	implement	VERB
globalce-210	98	19	than	than	SCONJ
globalce-210	98	20	by	by	ADP
globalce-210	98	21	epa.37	epa.37	PROPN
globalce-210	98	22	india	india	PROPN
globalce-210	98	23	’s	’s	PART
globalce-210	98	24	central	central	ADJ
globalce-210	98	25	drugs	drug	NOUN
globalce-210	98	26	standard	standard	PROPN
globalce-210	98	27	control	control	PROPN
globalce-210	98	28	organization	organization	PROPN
globalce-210	98	29	17	17	NUM
globalce-210	98	30	j	j	PROPN
globalce-210	98	31	global	global	ADJ
globalce-210	98	32	clinical	clinical	ADJ
globalce-210	98	33	engineering	engineering	NOUN
globalce-210	98	34	vol.7	vol.7	PROPN
globalce-210	98	35	issue	issue	NOUN
globalce-210	98	36	2	2	NUM
globalce-210	98	37	:	:	SYM
globalce-210	98	38	2025	2025	NUM
globalce-210	98	39	gaur	gaur	NOUN
globalce-210	98	40	,	,	PUNCT
globalce-210	98	41	akram	akram	PROPN
globalce-210	98	42	,	,	PUNCT
globalce-210	98	43	singh	singh	PROPN
globalce-210	98	44	,	,	PUNCT
globalce-210	98	45	chauhan	chauhan	PROPN
globalce-210	98	46	:	:	PUNCT
globalce-210	98	47	artificial	artificial	ADJ
globalce-210	98	48	intelligence	intelligence	NOUN
globalce-210	98	49	-	-	PUNCT
globalce-210	98	50	driven	drive	VERB
globalce-210	98	51	insights	insight	NOUN
globalce-210	98	52	for	for	ADP
globalce-210	98	53	regulatory	regulatory	ADJ
globalce-210	98	54	intelligence	intelligence	NOUN
globalce-210	98	55	in	in	ADP
globalce-210	98	56	medical	medical	ADJ
globalce-210	98	57	devices	device	NOUN
globalce-210	98	58	:	:	PUNCT
globalce-210	98	59	evaluating	evaluate	VERB
globalce-210	98	60	ema	ema	PROPN
globalce-210	98	61	,	,	PUNCT
globalce-210	98	62	fda	fda	PROPN
globalce-210	98	63	,	,	PUNCT
globalce-210	98	64	and	and	CCONJ
globalce-210	98	65	cdsco	cdsco	PROPN
globalce-210	98	66	frameworks	framework	VERB
globalce-210	98	67	india	india	PROPN
globalce-210	98	68	’s	’s	PART
globalce-210	98	69	central	central	ADJ
globalce-210	98	70	drugs	drug	NOUN
globalce-210	98	71	standard	standard	PROPN
globalce-210	98	72	control	control	PROPN
globalce-210	98	73	organization	organization	PROPN
globalce-210	98	74	cdsco	cdsco	PROPN
globalce-210	98	75	’s	’s	PART
globalce-210	98	76	alignment	alignment	NOUN
globalce-210	98	77	with	with	ADP
globalce-210	98	78	imdrf	imdrf	PROPN
globalce-210	98	79	guidelines	guideline	NOUN
globalce-210	98	80	the	the	DET
globalce-210	98	81	cdsco	cdsco	PROPN
globalce-210	98	82	is	be	AUX
globalce-210	98	83	aligning	align	VERB
globalce-210	98	84	its	its	PRON
globalce-210	98	85	medical	medical	ADJ
globalce-210	98	86	device	device	NOUN
globalce-210	98	87	rules	rule	NOUN
globalce-210	98	88	with	with	ADP
globalce-210	98	89	imdrf	imdrf	NOUN
globalce-210	98	90	guidelines	guideline	NOUN
globalce-210	98	91	.	.	PUNCT
globalce-210	99	1	the	the	DET
globalce-210	99	2	cdsco	cdsco	PROPN
globalce-210	99	3	issued	issue	VERB
globalce-210	99	4	a	a	DET
globalce-210	99	5	notification	notification	NOUN
globalce-210	99	6	on	on	ADP
globalce-210	99	7	august	august	PROPN
globalce-210	99	8	1	1	NUM
globalce-210	99	9	,	,	PUNCT
globalce-210	99	10	2019	2019	NUM
globalce-210	99	11	,	,	PUNCT
globalce-210	99	12	revising	revise	VERB
globalce-210	99	13	the	the	DET
globalce-210	99	14	medical	medical	ADJ
globalce-210	99	15	devices	device	NOUN
globalce-210	99	16	rules	rule	NOUN
globalce-210	99	17	of	of	ADP
globalce-210	99	18	2017	2017	NUM
globalce-210	99	19	to	to	PART
globalce-210	99	20	make	make	VERB
globalce-210	99	21	samd	samd	ADJ
globalce-210	99	22	subject	subject	ADJ
globalce-210	99	23	to	to	ADP
globalce-210	99	24	its	its	PRON
globalce-210	99	25	existing	exist	VERB
globalce-210	99	26	regulatory	regulatory	ADJ
globalce-210	99	27	framework	framework	NOUN
globalce-210	99	28	.	.	PUNCT
globalce-210	100	1	following	follow	VERB
globalce-210	100	2	the	the	DET
globalce-210	100	3	imdrf	imdrf	NOUN
globalce-210	100	4	guidelines	guideline	NOUN
globalce-210	100	5	provides	provide	VERB
globalce-210	100	6	a	a	DET
globalce-210	100	7	road	road	NOUN
globalce-210	100	8	map	map	NOUN
globalce-210	100	9	to	to	ADP
globalce-210	100	10	manufacturers	manufacturer	NOUN
globalce-210	100	11	in	in	ADP
globalce-210	100	12	india	india	PROPN
globalce-210	100	13	by	by	ADP
globalce-210	100	14	which	which	PRON
globalce-210	100	15	they	they	PRON
globalce-210	100	16	can	can	AUX
globalce-210	100	17	comply	comply	VERB
globalce-210	100	18	with	with	ADP
globalce-210	100	19	their	their	PRON
globalce-210	100	20	regulatory	regulatory	ADJ
globalce-210	100	21	obligations	obligation	NOUN
globalce-210	100	22	for	for	ADP
globalce-210	100	23	samd	samd	ADJ
globalce-210	100	24	products	product	NOUN
globalce-210	100	25	.	.	PUNCT
globalce-210	101	1	samds	samds	NOUN
globalce-210	101	2	are	be	AUX
globalce-210	101	3	classified	classify	VERB
globalce-210	101	4	into	into	ADP
globalce-210	101	5	risk	risk	NOUN
globalce-210	101	6	-	-	PUNCT
globalce-210	101	7	based	base	VERB
globalce-210	101	8	classes	class	NOUN
globalce-210	101	9	(	(	PUNCT
globalce-210	101	10	a	a	DET
globalce-210	101	11	–	–	PUNCT
globalce-210	101	12	d	d	NOUN
globalce-210	101	13	)	)	PUNCT
globalce-210	101	14	,	,	PUNCT
globalce-210	101	15	which	which	PRON
globalce-210	101	16	are	be	AUX
globalce-210	101	17	systematically	systematically	ADV
globalce-210	101	18	defined	define	VERB
globalce-210	101	19	as	as	ADP
globalce-210	101	20	per	per	ADP
globalce-210	101	21	the	the	DET
globalce-210	101	22	imdrf	imdrf	ADJ
globalce-210	101	23	risk	risk	NOUN
globalce-210	101	24	framework.38	framework.38	PROPN
globalce-210	101	25	it	it	PRON
globalce-210	101	26	determines	determine	VERB
globalce-210	101	27	the	the	DET
globalce-210	101	28	required	required	ADJ
globalce-210	101	29	level	level	NOUN
globalce-210	101	30	of	of	ADP
globalce-210	101	31	regulatory	regulatory	ADJ
globalce-210	101	32	oversight	oversight	NOUN
globalce-210	101	33	and	and	CCONJ
globalce-210	101	34	compliance	compliance	NOUN
globalce-210	101	35	.	.	PUNCT
globalce-210	102	1	the	the	DET
globalce-210	102	2	cdsco	cdsco	PROPN
globalce-210	102	3	is	be	AUX
globalce-210	102	4	working	work	VERB
globalce-210	102	5	on	on	ADP
globalce-210	102	6	creating	create	VERB
globalce-210	102	7	a	a	DET
globalce-210	102	8	digital	digital	ADJ
globalce-210	102	9	drugs	drug	NOUN
globalce-210	102	10	regulatory	regulatory	ADJ
globalce-210	102	11	system	system	NOUN
globalce-210	102	12	(	(	PUNCT
globalce-210	102	13	ddrs	ddr	NOUN
globalce-210	102	14	)	)	PUNCT
globalce-210	102	15	,	,	PUNCT
globalce-210	102	16	which	which	PRON
globalce-210	102	17	,	,	PUNCT
globalce-210	102	18	however	however	ADV
globalce-210	102	19	,	,	PUNCT
globalce-210	102	20	is	be	AUX
globalce-210	102	21	an	an	DET
globalce-210	102	22	ai	ai	NOUN
globalce-210	102	23	-	-	PUNCT
globalce-210	102	24	enabled	enable	VERB
globalce-210	102	25	open	open	ADJ
globalce-210	102	26	-	-	PUNCT
globalce-210	102	27	source	source	NOUN
globalce-210	102	28	technology	technology	NOUN
globalce-210	102	29	.	.	PUNCT
globalce-210	103	1	the	the	DET
globalce-210	103	2	goal	goal	NOUN
globalce-210	103	3	is	be	AUX
globalce-210	103	4	to	to	PART
globalce-210	103	5	create	create	VERB
globalce-210	103	6	a	a	DET
globalce-210	103	7	harmonious	harmonious	ADJ
globalce-210	103	8	digital	digital	ADJ
globalce-210	103	9	regulatory	regulatory	ADJ
globalce-210	103	10	environment	environment	NOUN
globalce-210	103	11	based	base	VERB
globalce-210	103	12	on	on	ADP
globalce-210	103	13	international	international	ADJ
globalce-210	103	14	standards	standard	NOUN
globalce-210	103	15	and	and	CCONJ
globalce-210	103	16	best	good	ADJ
globalce-210	103	17	practices	practice	NOUN
globalce-210	103	18	.	.	PUNCT
globalce-210	104	1	as	as	ADV
globalce-210	104	2	long	long	ADV
globalce-210	104	3	as	as	SCONJ
globalce-210	104	4	ai	ai	ADP
globalce-210	104	5	medical	medical	ADJ
globalce-210	104	6	devices	device	NOUN
globalce-210	104	7	safeguard	safeguard	VERB
globalce-210	104	8	patient	patient	ADJ
globalce-210	104	9	data	datum	NOUN
globalce-210	104	10	and	and	CCONJ
globalce-210	104	11	offer	offer	VERB
globalce-210	104	12	safe	safe	ADJ
globalce-210	104	13	access	access	NOUN
globalce-210	104	14	to	to	ADP
globalce-210	104	15	it	it	PRON
globalce-210	104	16	for	for	ADP
globalce-210	104	17	unauthorized	unauthorized	ADJ
globalce-210	104	18	parties	party	NOUN
globalce-210	104	19	as	as	SCONJ
globalce-210	104	20	defined	define	VERB
globalce-210	104	21	by	by	ADP
globalce-210	104	22	new	new	ADJ
globalce-210	104	23	legislation	legislation	NOUN
globalce-210	104	24	,	,	PUNCT
globalce-210	104	25	they	they	PRON
globalce-210	104	26	can	can	AUX
globalce-210	104	27	continue	continue	VERB
globalce-210	104	28	to	to	PART
globalce-210	104	29	be	be	AUX
globalce-210	104	30	relevant	relevant	ADJ
globalce-210	104	31	in	in	ADP
globalce-210	104	32	accordance	accordance	NOUN
globalce-210	104	33	with	with	ADP
globalce-210	104	34	the	the	DET
globalce-210	104	35	ethical	ethical	ADJ
globalce-210	104	36	and	and	CCONJ
globalce-210	104	37	open	open	ADJ
globalce-210	104	38	principles	principle	NOUN
globalce-210	104	39	outlined	outline	VERB
globalce-210	104	40	by	by	ADP
globalce-210	104	41	the	the	DET
globalce-210	104	42	imdrf	imdrf	NOUN
globalce-210	104	43	.	.	PUNCT
globalce-210	105	1	the	the	DET
globalce-210	105	2	cdsco	cdsco	PROPN
globalce-210	105	3	has	have	AUX
globalce-210	105	4	leaned	lean	VERB
globalce-210	105	5	into	into	ADP
globalce-210	105	6	the	the	DET
globalce-210	105	7	imdrf	imdrf	NOUN
globalce-210	105	8	guidance	guidance	NOUN
globalce-210	105	9	as	as	ADP
globalce-210	105	10	a	a	DET
globalce-210	105	11	way	way	NOUN
globalce-210	105	12	of	of	ADP
globalce-210	105	13	developing	develop	VERB
globalce-210	105	14	its	its	PRON
globalce-210	105	15	medical	medical	ADJ
globalce-210	105	16	device	device	NOUN
globalce-210	105	17	regulations	regulation	NOUN
globalce-210	105	18	,	,	PUNCT
globalce-210	105	19	with	with	ADP
globalce-210	105	20	an	an	DET
globalce-210	105	21	emphasis	emphasis	NOUN
globalce-210	105	22	on	on	ADP
globalce-210	105	23	technologies	technology	NOUN
globalce-210	105	24	such	such	ADJ
globalce-210	105	25	as	as	ADP
globalce-210	105	26	ai	ai	NOUN
globalce-210	105	27	-	-	PUNCT
globalce-210	105	28	powered	power	VERB
globalce-210	105	29	samds	samds	NOUN
globalce-210	105	30	.	.	PUNCT
globalce-210	106	1	the	the	DET
globalce-210	106	2	aim	aim	NOUN
globalce-210	106	3	is	be	AUX
globalce-210	106	4	to	to	PART
globalce-210	106	5	have	have	VERB
globalce-210	106	6	a	a	PRON
globalce-210	106	7	robust	robust	ADJ
globalce-210	106	8	,	,	PUNCT
globalce-210	106	9	risk	risk	NOUN
globalce-210	106	10	-	-	PUNCT
globalce-210	106	11	based	base	VERB
globalce-210	106	12	,	,	PUNCT
globalce-210	106	13	and	and	CCONJ
globalce-210	106	14	globally	globally	ADV
globalce-210	106	15	harmonized	harmonized	ADJ
globalce-210	106	16	regulatory	regulatory	ADJ
globalce-210	106	17	system	system	NOUN
globalce-210	106	18	for	for	ADP
globalce-210	106	19	medical	medical	ADJ
globalce-210	106	20	devices	device	NOUN
globalce-210	106	21	in	in	ADP
globalce-210	106	22	india.39,40	india.39,40	ADJ
globalce-210	106	23	overview	overview	NOUN
globalce-210	106	24	of	of	ADP
globalce-210	106	25	imdrf	imdrf	NOUN
globalce-210	106	26	guidelines	guideline	NOUN
globalce-210	106	27	for	for	ADP
globalce-210	106	28	medical	medical	ADJ
globalce-210	106	29	devices	device	NOUN
globalce-210	106	30	:	:	PUNCT
globalce-210	106	31	the	the	DET
globalce-210	106	32	imdrf	imdrf	NOUN
globalce-210	106	33	has	have	AUX
globalce-210	106	34	published	publish	VERB
globalce-210	106	35	a	a	DET
globalce-210	106	36	framework	framework	NOUN
globalce-210	106	37	,	,	PUNCT
globalce-210	106	38	which	which	PRON
globalce-210	106	39	is	be	AUX
globalce-210	106	40	adopted	adopt	VERB
globalce-210	106	41	and	and	CCONJ
globalce-210	106	42	applied	apply	VERB
globalce-210	106	43	by	by	ADP
globalce-210	106	44	the	the	DET
globalce-210	106	45	cdsco	cdsco	PROPN
globalce-210	106	46	.	.	PUNCT
globalce-210	107	1	main	main	ADJ
globalce-210	107	2	safety	safety	NOUN
globalce-210	107	3	and	and	CCONJ
globalce-210	107	4	performance	performance	NOUN
globalce-210	107	5	imdrf	imdrf	NOUN
globalce-210	107	6	regulations	regulation	NOUN
globalce-210	107	7	are	be	AUX
globalce-210	107	8	as	as	SCONJ
globalce-210	107	9	follows	follow	VERB
globalce-210	107	10	:	:	PUNCT
globalce-210	107	11	imdrf	imdrf	PROPN
globalce-210	107	12	has	have	AUX
globalce-210	107	13	released	release	VERB
globalce-210	107	14	the	the	DET
globalce-210	107	15	document	document	NOUN
globalce-210	107	16	“	"	PUNCT
globalce-210	107	17	essential	essential	ADJ
globalce-210	107	18	principles	principle	NOUN
globalce-210	107	19	of	of	ADP
globalce-210	107	20	safety	safety	NOUN
globalce-210	107	21	and	and	CCONJ
globalce-210	107	22	performance	performance	NOUN
globalce-210	107	23	for	for	ADP
globalce-210	107	24	medical	medical	ADJ
globalce-210	107	25	devices	device	NOUN
globalce-210	107	26	&	&	CCONJ
globalce-210	107	27	ivds	ivds	PROPN
globalce-210	107	28	”	"	PUNCT
globalce-210	107	29	(	(	PUNCT
globalce-210	107	30	imdrf	imdrf	PROPN
globalce-210	107	31	/	/	SYM
globalce-210	107	32	grrp	grrp	PROPN
globalce-210	107	33	wg	wg	PROPN
globalce-210	107	34	/	/	SYM
globalce-210	107	35	n47	n47	PROPN
globalce-210	107	36	)	)	PUNCT
globalce-210	107	37	.	.	PUNCT
globalce-210	108	1	this	this	DET
globalce-210	108	2	guidance	guidance	NOUN
globalce-210	108	3	provides	provide	VERB
globalce-210	108	4	highaltitude	highaltitude	ADJ
globalce-210	108	5	rules	rule	NOUN
globalce-210	108	6	on	on	ADP
globalce-210	108	7	designing	design	VERB
globalce-210	108	8	and	and	CCONJ
globalce-210	108	9	constructing	construct	VERB
globalce-210	108	10	medical	medical	ADJ
globalce-210	108	11	devices	device	NOUN
globalce-210	108	12	to	to	PART
globalce-210	108	13	make	make	VERB
globalce-210	108	14	them	they	PRON
globalce-210	108	15	safe	safe	ADJ
globalce-210	108	16	,	,	PUNCT
globalce-210	108	17	by	by	ADP
globalce-210	108	18	following	follow	VERB
globalce-210	108	19	which	which	PRON
globalce-210	108	20	you	you	PRON
globalce-210	108	21	can	can	AUX
globalce-210	108	22	guarantee	guarantee	VERB
globalce-210	108	23	the	the	DET
globalce-210	108	24	safety	safety	NOUN
globalce-210	108	25	characteristics	characteristic	NOUN
globalce-210	108	26	that	that	PRON
globalce-210	108	27	are	be	AUX
globalce-210	108	28	in	in	ADP
globalce-210	108	29	place	place	NOUN
globalce-210	108	30	when	when	SCONJ
globalce-210	108	31	your	your	PRON
globalce-210	108	32	device	device	NOUN
globalce-210	108	33	is	be	AUX
globalce-210	108	34	used	use	VERB
globalce-210	108	35	as	as	ADP
globalce-210	108	36	intended	intend	VERB
globalce-210	108	37	.	.	PUNCT
globalce-210	109	1	imdrf	imdrf	PROPN
globalce-210	109	2	/	/	SYM
globalce-210	109	3	grrp	grrp	PROPN
globalce-210	109	4	wg	wg	PROPN
globalce-210	109	5	/	/	SYM
globalce-210	109	6	n71:2021	n71:2021	PROPN
globalce-210	109	7	medical	medical	ADJ
globalce-210	109	8	device	device	NOUN
globalce-210	109	9	regulatory	regulatory	ADJ
globalce-210	109	10	review	review	NOUN
globalce-210	109	11	reports	report	VERB
globalce-210	109	12	guidance	guidance	NOUN
globalce-210	109	13	regarding	regard	VERB
globalce-210	109	14	information	information	NOUN
globalce-210	109	15	to	to	PART
globalce-210	109	16	be	be	AUX
globalce-210	109	17	included	include	VERB
globalce-210	109	18	(	(	PUNCT
globalce-210	109	19	imdrf	imdrf	PROPN
globalce-210	109	20	/	/	SYM
globalce-210	109	21	grrp	grrp	PROPN
globalce-210	109	22	,	,	PUNCT
globalce-210	109	23	2020	2020	NUM
globalce-210	109	24	)	)	PUNCT
globalce-210	109	25	.	.	PUNCT
globalce-210	110	1	the	the	DET
globalce-210	110	2	guidance	guidance	NOUN
globalce-210	110	3	is	be	AUX
globalce-210	110	4	to	to	PART
globalce-210	110	5	provide	provide	VERB
globalce-210	110	6	common	common	ADJ
globalce-210	110	7	format	format	NOUN
globalce-210	110	8	requirements	requirement	NOUN
globalce-210	110	9	for	for	ADP
globalce-210	110	10	the	the	DET
globalce-210	110	11	content	content	NOUN
globalce-210	110	12	and	and	CCONJ
globalce-210	110	13	format	format	NOUN
globalce-210	110	14	of	of	ADP
globalce-210	110	15	a	a	DET
globalce-210	110	16	regulatory	regulatory	ADJ
globalce-210	110	17	submission	submission	NOUN
globalce-210	110	18	dossier	dossier	NOUN
globalce-210	110	19	for	for	ADP
globalce-210	110	20	a	a	DET
globalce-210	110	21	medical	medical	ADJ
globalce-210	110	22	device.41	device.41	NOUN
globalce-210	110	23	this	this	DET
globalce-210	110	24	report	report	NOUN
globalce-210	110	25	encompasses	encompass	VERB
globalce-210	110	26	crucial	crucial	ADJ
globalce-210	110	27	sections	section	NOUN
globalce-210	110	28	,	,	PUNCT
globalce-210	110	29	such	such	ADJ
globalce-210	110	30	as	as	ADP
globalce-210	110	31	the	the	DET
globalce-210	110	32	following	following	NOUN
globalce-210	110	33	:	:	PUNCT
globalce-210	110	34	regional	regional	ADJ
globalce-210	110	35	administrative	administrative	ADJ
globalce-210	110	36	information	information	NOUN
globalce-210	110	37	submission	submission	NOUN
globalce-210	110	38	context	context	NOUN
globalce-210	110	39	nonclinical	nonclinical	ADJ
globalce-210	110	40	evidence	evidence	NOUN
globalce-210	110	41	clinical	clinical	ADJ
globalce-210	110	42	evidence	evidence	NOUN
globalce-210	110	43	labeling	labeling	NOUN
globalce-210	110	44	and	and	CCONJ
globalce-210	110	45	promotional	promotional	ADJ
globalce-210	110	46	material	material	NOUN
globalce-210	110	47	quality	quality	NOUN
globalce-210	110	48	management	management	NOUN
globalce-210	110	49	system	system	NOUN
globalce-210	110	50	information	information	NOUN
globalce-210	110	51	there	there	PRON
globalce-210	110	52	are	be	VERB
globalce-210	110	53	rules	rule	NOUN
globalce-210	110	54	and	and	CCONJ
globalce-210	110	55	principles	principle	NOUN
globalce-210	110	56	for	for	ADP
globalce-210	110	57	medical	medical	ADJ
globalce-210	110	58	devices	device	NOUN
globalce-210	110	59	in	in	ADP
globalce-210	110	60	india	india	PROPN
globalce-210	110	61	that	that	PRON
globalce-210	110	62	were	be	AUX
globalce-210	110	63	taken	take	VERB
globalce-210	110	64	from	from	ADP
globalce-210	110	65	the	the	DET
globalce-210	110	66	imdrf	imdrf	NOUN
globalce-210	110	67	and	and	CCONJ
globalce-210	110	68	added	add	VERB
globalce-210	110	69	by	by	ADP
globalce-210	110	70	the	the	DET
globalce-210	110	71	cdsco	cdsco	PROPN
globalce-210	110	72	to	to	ADP
globalce-210	110	73	the	the	DET
globalce-210	110	74	medical	medical	ADJ
globalce-210	110	75	devices	device	NOUN
globalce-210	110	76	rules	rule	NOUN
globalce-210	110	77	,	,	PUNCT
globalce-210	110	78	2017	2017	NUM
globalce-210	110	79	.	.	PUNCT
globalce-210	111	1	the	the	DET
globalce-210	111	2	cdsco	cdsco	PROPN
globalce-210	111	3	also	also	ADV
globalce-210	111	4	publishes	publish	VERB
globalce-210	111	5	lists	list	NOUN
globalce-210	111	6	of	of	ADP
globalce-210	111	7	medical	medical	ADJ
globalce-210	111	8	devices	device	NOUN
globalce-210	111	9	that	that	PRON
globalce-210	111	10	are	be	AUX
globalce-210	111	11	categorized	categorize	VERB
globalce-210	111	12	by	by	ADP
globalce-210	111	13	risk	risk	NOUN
globalce-210	111	14	.	.	PUNCT
globalce-210	112	1	these	these	DET
globalce-210	112	2	lists	list	NOUN
globalce-210	112	3	match	match	VERB
globalce-210	112	4	the	the	DET
globalce-210	112	5	imdrf	imdrf	NOUN
globalce-210	112	6	framework	framework	NOUN
globalce-210	112	7	of	of	ADP
globalce-210	112	8	classes	class	NOUN
globalce-210	112	9	a	a	PRON
globalce-210	112	10	–	–	PUNCT
globalce-210	112	11	d	d	NOUN
globalce-210	112	12	based	base	VERB
globalce-210	112	13	on	on	ADP
globalce-210	112	14	risk.42	risk.42	PROPN
globalce-210	112	15	implications	implication	NOUN
globalce-210	112	16	of	of	ADP
globalce-210	112	17	cdsco	cdsco	PROPN
globalce-210	112	18	’s	’s	PART
globalce-210	112	19	alignment	alignment	NOUN
globalce-210	112	20	with	with	ADP
globalce-210	112	21	imdrf	imdrf	NOUN
globalce-210	112	22	guidelines	guideline	NOUN
globalce-210	112	23	for	for	ADP
globalce-210	112	24	ai	ai	ADV
globalce-210	112	25	-	-	PUNCT
globalce-210	112	26	based	base	VERB
globalce-210	112	27	medical	medical	ADJ
globalce-210	112	28	devices	device	NOUN
globalce-210	112	29	in	in	ADP
globalce-210	112	30	india	india	PROPN
globalce-210	112	31	:	:	PUNCT
globalce-210	112	32	in	in	ADP
globalce-210	112	33	india	india	PROPN
globalce-210	112	34	,	,	PUNCT
globalce-210	112	35	the	the	DET
globalce-210	112	36	cdsco	cdsco	NOUN
globalce-210	112	37	has	have	AUX
globalce-210	112	38	mostly	mostly	ADV
globalce-210	112	39	made	make	VERB
globalce-210	112	40	its	its	PRON
globalce-210	112	41	rules	rule	NOUN
globalce-210	112	42	about	about	ADP
globalce-210	112	43	medical	medical	ADJ
globalce-210	112	44	devices	device	NOUN
globalce-210	112	45	,	,	PUNCT
globalce-210	112	46	such	such	ADJ
globalce-210	112	47	as	as	ADP
globalce-210	112	48	samds	samds	NOUN
globalce-210	112	49	,	,	PUNCT
globalce-210	112	50	the	the	DET
globalce-210	112	51	same	same	ADJ
globalce-210	112	52	as	as	ADP
globalce-210	112	53	the	the	DET
globalce-210	112	54	rules	rule	NOUN
globalce-210	112	55	and	and	CCONJ
globalce-210	112	56	guidelines	guideline	NOUN
globalce-210	112	57	set	set	VERB
globalce-210	112	58	by	by	ADP
globalce-210	112	59	the	the	DET
globalce-210	112	60	imdrf	imdrf	NOUN
globalce-210	112	61	.	.	PUNCT
globalce-210	113	1	the	the	DET
globalce-210	113	2	cdsco	cdsco	PROPN
globalce-210	113	3	has	have	AUX
globalce-210	113	4	implemented	implement	VERB
globalce-210	113	5	the	the	DET
globalce-210	113	6	imdrf	imdrf	NOUN
globalce-210	113	7	’s	’s	PART
globalce-210	113	8	risk	risk	NOUN
globalce-210	113	9	-	-	PUNCT
globalce-210	113	10	based	base	VERB
globalce-210	113	11	system	system	NOUN
globalce-210	113	12	to	to	PART
globalce-210	113	13	categorize	categorize	VERB
globalce-210	113	14	samds	samds	NOUN
globalce-210	113	15	into	into	ADP
globalce-210	113	16	four	four	NUM
globalce-210	113	17	groups	group	NOUN
globalce-210	113	18	based	base	VERB
globalce-210	113	19	on	on	ADP
globalce-210	113	20	their	their	PRON
globalce-210	113	21	level	level	NOUN
globalce-210	113	22	of	of	ADP
globalce-210	113	23	risk	risk	NOUN
globalce-210	113	24	:	:	PUNCT
globalce-210	113	25	low	low	ADJ
globalce-210	113	26	-	-	PUNCT
globalce-210	113	27	risk	risk	NOUN
globalce-210	113	28	(	(	PUNCT
globalce-210	113	29	class	class	NOUN
globalce-210	113	30	a	a	NOUN
globalce-210	113	31	)	)	PUNCT
globalce-210	113	32	,	,	PUNCT
globalce-210	113	33	low	low	ADJ
globalce-210	113	34	–	–	PUNCT
globalce-210	113	35	moderate	moderate	ADJ
globalce-210	113	36	risk	risk	NOUN
globalce-210	113	37	(	(	PUNCT
globalce-210	113	38	class	class	NOUN
globalce-210	113	39	b	b	NOUN
globalce-210	113	40	)	)	PUNCT
globalce-210	113	41	,	,	PUNCT
globalce-210	113	42	moderate	moderate	ADJ
globalce-210	113	43	risk	risk	NOUN
globalce-210	113	44	(	(	PUNCT
globalce-210	113	45	class	class	NOUN
globalce-210	113	46	c	c	NOUN
globalce-210	113	47	)	)	PUNCT
globalce-210	113	48	,	,	PUNCT
globalce-210	113	49	and	and	CCONJ
globalce-210	113	50	high	high	ADJ
globalce-210	113	51	-	-	PUNCT
globalce-210	113	52	risk	risk	NOUN
globalce-210	113	53	(	(	PUNCT
globalce-210	113	54	class	class	NOUN
globalce-210	113	55	d	d	NOUN
globalce-210	113	56	)	)	PUNCT
globalce-210	113	57	.	.	PUNCT
globalce-210	114	1	essential	essential	ADJ
globalce-210	114	2	principles	principle	NOUN
globalce-210	114	3	of	of	ADP
globalce-210	114	4	safety	safety	NOUN
globalce-210	114	5	and	and	CCONJ
globalce-210	114	6	performance	performance	NOUN
globalce-210	114	7	:	:	PUNCT
globalce-210	114	8	the	the	DET
globalce-210	114	9	cdsco	cdsco	PROPN
globalce-210	114	10	makes	make	VERB
globalce-210	114	11	sure	sure	ADJ
globalce-210	114	12	that	that	DET
globalce-210	114	13	samds	samds	NOUN
globalce-210	114	14	follow	follow	VERB
globalce-210	114	15	the	the	DET
globalce-210	114	16	imdrf	imdrf	NOUN
globalce-210	114	17	’s	’s	PART
globalce-210	114	18	“	"	PUNCT
globalce-210	114	19	essential	essential	ADJ
globalce-210	114	20	principles	principle	NOUN
globalce-210	114	21	of	of	ADP
globalce-210	114	22	safety	safety	NOUN
globalce-210	114	23	and	and	CCONJ
globalce-210	114	24	performance	performance	NOUN
globalce-210	114	25	of	of	ADP
globalce-210	114	26	medical	medical	ADJ
globalce-210	114	27	devices	device	NOUN
globalce-210	114	28	and	and	CCONJ
globalce-210	114	29	ivd	ivd	PROPN
globalce-210	114	30	medical	medical	ADJ
globalce-210	114	31	devices	device	NOUN
globalce-210	114	32	”	"	PUNCT
globalce-210	114	33	when	when	SCONJ
globalce-210	114	34	they	they	PRON
globalce-210	114	35	design	design	VERB
globalce-210	114	36	and	and	CCONJ
globalce-210	114	37	make	make	VERB
globalce-210	114	38	their	their	PRON
globalce-210	114	39	products	product	NOUN
globalce-210	114	40	.	.	PUNCT
globalce-210	115	1	labeling	labeling	NOUN
globalce-210	115	2	and	and	CCONJ
globalce-210	115	3	advertising	advertising	NOUN
globalce-210	115	4	:	:	PUNCT
globalce-210	115	5	in	in	ADP
globalce-210	115	6	india	india	PROPN
globalce-210	115	7	,	,	PUNCT
globalce-210	115	8	samds	samds	NOUN
globalce-210	115	9	must	must	AUX
globalce-210	115	10	follow	follow	VERB
globalce-210	115	11	the	the	DET
globalce-210	115	12	imdrf	imdrf	NOUN
globalce-210	115	13	’s	’s	PART
globalce-210	115	14	“	"	PUNCT
globalce-210	115	15	principles	principle	NOUN
globalce-210	115	16	of	of	ADP
globalce-210	115	17	labeling	labeling	NOUN
globalce-210	115	18	for	for	ADP
globalce-210	115	19	medical	medical	ADJ
globalce-210	115	20	devices	device	NOUN
globalce-210	115	21	and	and	CCONJ
globalce-210	115	22	ivd	ivd	PROPN
globalce-210	115	23	medical	medical	ADJ
globalce-210	115	24	devices	device	NOUN
globalce-210	115	25	”	"	PUNCT
globalce-210	115	26	to	to	PART
globalce-210	115	27	make	make	VERB
globalce-210	115	28	sure	sure	ADJ
globalce-210	115	29	users	user	NOUN
globalce-210	115	30	get	get	VERB
globalce-210	115	31	the	the	DET
globalce-210	115	32	right	right	ADJ
globalce-210	115	33	information	information	NOUN
globalce-210	115	34	.	.	PUNCT
globalce-210	116	1	structure	structure	NOUN
globalce-210	116	2	of	of	ADP
globalce-210	116	3	regulatory	regulatory	ADJ
globalce-210	116	4	submissions	submission	NOUN
globalce-210	116	5	:	:	PUNCT
globalce-210	116	6	the	the	DET
globalce-210	116	7	cdsco	cdsco	PROPN
globalce-210	116	8	has	have	AUX
globalce-210	116	9	used	use	VERB
globalce-210	116	10	the	the	DET
globalce-210	116	11	imdrf	imdrf	NOUN
globalce-210	116	12	’s	’s	PART
globalce-210	116	13	“	"	PUNCT
globalce-210	116	14	medical	medical	ADJ
globalce-210	116	15	device	device	NOUN
globalce-210	116	16	regulatory	regulatory	ADJ
globalce-210	116	17	review	review	NOUN
globalce-210	116	18	report	report	NOUN
globalce-210	116	19	”	"	PUNCT
globalce-210	116	20	template	template	NOUN
globalce-210	116	21	to	to	PART
globalce-210	116	22	decide	decide	VERB
globalce-210	116	23	the	the	DET
globalce-210	116	24	information	information	NOUN
globalce-210	116	25	that	that	PRON
globalce-210	116	26	should	should	AUX
globalce-210	116	27	be	be	AUX
globalce-210	116	28	included	include	VERB
globalce-210	116	29	and	and	CCONJ
globalce-210	116	30	how	how	SCONJ
globalce-210	116	31	it	it	PRON
globalce-210	116	32	should	should	AUX
globalce-210	116	33	be	be	AUX
globalce-210	116	34	organized	organize	VERB
globalce-210	116	35	in	in	ADP
globalce-210	116	36	regulatory	regulatory	ADJ
globalce-210	116	37	submissions	submission	NOUN
globalce-210	116	38	for	for	ADP
globalce-210	116	39	samds	samds	NOUN
globalce-210	116	40	.	.	PUNCT
globalce-210	117	1	gaur	gaur	PROPN
globalce-210	117	2	,	,	PUNCT
globalce-210	117	3	akram	akram	PROPN
globalce-210	117	4	,	,	PUNCT
globalce-210	117	5	singh	singh	PROPN
globalce-210	117	6	,	,	PUNCT
globalce-210	117	7	chauhan	chauhan	PROPN
globalce-210	117	8	:	:	PUNCT
globalce-210	117	9	artificial	artificial	ADJ
globalce-210	117	10	intelligence	intelligence	NOUN
globalce-210	117	11	-	-	PUNCT
globalce-210	117	12	driven	drive	VERB
globalce-210	117	13	insights	insight	NOUN
globalce-210	117	14	for	for	ADP
globalce-210	117	15	regulatory	regulatory	ADJ
globalce-210	117	16	intelligence	intelligence	NOUN
globalce-210	117	17	in	in	ADP
globalce-210	117	18	medical	medical	ADJ
globalce-210	117	19	devices	device	NOUN
globalce-210	117	20	:	:	PUNCT
globalce-210	117	21	evaluating	evaluate	VERB
globalce-210	117	22	ema	ema	PROPN
globalce-210	117	23	,	,	PUNCT
globalce-210	117	24	fda	fda	PROPN
globalce-210	117	25	,	,	PUNCT
globalce-210	117	26	and	and	CCONJ
globalce-210	117	27	cdsco	cdsco	PROPN
globalce-210	117	28	frameworks	framework	VERB
globalce-210	117	29	j	j	PROPN
globalce-210	117	30	global	global	ADJ
globalce-210	117	31	clinical	clinical	ADJ
globalce-210	117	32	engineering	engineering	NOUN
globalce-210	117	33	vol.7	vol.7	PROPN
globalce-210	117	34	issue	issue	NOUN
globalce-210	117	35	2	2	NUM
globalce-210	117	36	:	:	SYM
globalce-210	117	37	2025	2025	NUM
globalce-210	117	38	18	18	NUM
globalce-210	117	39	table	table	NOUN
globalce-210	117	40	1	1	NUM
globalce-210	117	41	.	.	PUNCT
globalce-210	117	42	comparative	comparative	ADJ
globalce-210	117	43	analysis	analysis	NOUN
globalce-210	117	44	for	for	ADP
globalce-210	117	45	regulatory	regulatory	ADJ
globalce-210	117	46	framework	framework	NOUN
globalce-210	117	47	for	for	ADP
globalce-210	117	48	ai	ai	VERB
globalce-210	117	49	across	across	ADP
globalce-210	117	50	various	various	ADJ
globalce-210	117	51	regulatory	regulatory	ADJ
globalce-210	117	52	agencies	agency	NOUN
globalce-210	117	53	.	.	PUNCT
globalce-210	118	1	feature	feature	VERB
globalce-210	118	2	sub	sub	ADJ
globalce-210	118	3	-	-	ADJ
globalce-210	118	4	feature	feature	ADJ
globalce-210	118	5	european	european	PROPN
globalce-210	118	6	union	union	PROPN
globalce-210	118	7	(	(	PUNCT
globalce-210	118	8	eu	eu	PROPN
globalce-210	118	9	)	)	PUNCT
globalce-210	118	10	united	united	PROPN
globalce-210	118	11	states	states	PROPN
globalce-210	118	12	(	(	PUNCT
globalce-210	118	13	fda	fda	PROPN
globalce-210	118	14	)	)	PUNCT
globalce-210	118	15	india	india	PROPN
globalce-210	118	16	(	(	PUNCT
globalce-210	118	17	cdsco	cdsco	PROPN
globalce-210	118	18	)	)	PUNCT
globalce-210	118	19	focus	focus	VERB
globalce-210	118	20	regulatory	regulatory	ADJ
globalce-210	118	21	framework	framework	NOUN
globalce-210	118	22	for	for	ADP
globalce-210	118	23	ai	ai	NOUN
globalce-210	118	24	draft	draft	NOUN
globalce-210	118	25	reflection	reflection	NOUN
globalce-210	118	26	paper	paper	NOUN
globalce-210	118	27	on	on	ADP
globalce-210	118	28	ai	ai	NOUN
globalce-210	118	29	in	in	ADP
globalce-210	118	30	medicinal	medicinal	ADJ
globalce-210	118	31	products	product	NOUN
globalce-210	118	32	lifecycle	lifecycle	NOUN
globalce-210	118	33	defines	define	VERB
globalce-210	118	34	“	"	PUNCT
globalce-210	118	35	ai	ai	NOUN
globalce-210	118	36	system	system	NOUN
globalce-210	118	37	”	"	PUNCT
globalce-210	118	38	and	and	CCONJ
globalce-210	118	39	proposes	propose	VERB
globalce-210	118	40	regulatory	regulatory	ADJ
globalce-210	118	41	framework	framework	NOUN
globalce-210	118	42	.	.	PUNCT
globalce-210	119	1	eu	eu	PROPN
globalce-210	119	2	ai	ai	PROPN
globalce-210	119	3	act	act	NOUN
globalce-210	119	4	focuses	focus	VERB
globalce-210	119	5	on	on	ADP
globalce-210	119	6	general	general	ADJ
globalce-210	119	7	ai	ai	VERB
globalce-210	119	8	development	development	NOUN
globalce-210	119	9	and	and	CCONJ
globalce-210	119	10	ethical	ethical	ADJ
globalce-210	119	11	considerations	consideration	NOUN
globalce-210	119	12	.	.	PUNCT
globalce-210	120	1	ai	ai	VERB
globalce-210	120	2	/	/	SYM
globalce-210	120	3	ml	ml	NOUN
globalce-210	120	4	action	action	NOUN
globalce-210	120	5	plan	plan	NOUN
globalce-210	120	6	outlines	outline	NOUN
globalce-210	120	7	focus	focus	VERB
globalce-210	120	8	on	on	ADP
globalce-210	120	9	developing	develop	VERB
globalce-210	120	10	guidance	guidance	NOUN
globalce-210	120	11	for	for	ADP
globalce-210	120	12	ai	ai	NOUN
globalce-210	120	13	/	/	SYM
globalce-210	120	14	ml	ml	X
globalce-210	120	15	in	in	ADP
globalce-210	120	16	medical	medical	ADJ
globalce-210	120	17	devices.43	devices.43	PROPN
globalce-210	120	18	aligns	align	VERB
globalce-210	120	19	with	with	ADP
globalce-210	120	20	imdrf	imdrf	ADJ
globalce-210	120	21	principles	principle	NOUN
globalce-210	120	22	for	for	ADP
globalce-210	120	23	ai	ai	ADV
globalce-210	120	24	-	-	PUNCT
globalce-210	120	25	based	base	VERB
globalce-210	120	26	medical	medical	ADJ
globalce-210	120	27	devices.44	devices.44	NOUN
globalce-210	120	28	traditional	traditional	ADJ
globalce-210	120	29	premarket	premarket	NOUN
globalce-210	120	30	pathways	pathway	NOUN
globalce-210	120	31	existing	exist	VERB
globalce-210	120	32	ce	ce	PROPN
globalce-210	120	33	marking	mark	VERB
globalce-210	120	34	framework	framework	NOUN
globalce-210	120	35	with	with	ADP
globalce-210	120	36	risk	risk	NOUN
globalce-210	120	37	-	-	PUNCT
globalce-210	120	38	based	base	VERB
globalce-210	120	39	assessment	assessment	NOUN
globalce-210	120	40	considering	consider	VERB
globalce-210	120	41	ai	ai	VERB
globalce-210	120	42	components	component	NOUN
globalce-210	120	43	.	.	PUNCT
globalce-210	121	1	existing	exist	VERB
globalce-210	121	2	510	510	NUM
globalce-210	121	3	(	(	PUNCT
globalce-210	121	4	k	k	NOUN
globalce-210	121	5	)	)	PUNCT
globalce-210	121	6	clearance	clearance	NOUN
globalce-210	121	7	,	,	PUNCT
globalce-210	121	8	de	de	X
globalce-210	121	9	novo	novo	NOUN
globalce-210	121	10	classification	classification	NOUN
globalce-210	121	11	,	,	PUNCT
globalce-210	121	12	or	or	CCONJ
globalce-210	121	13	premarket	premarket	NOUN
globalce-210	121	14	approval	approval	NOUN
globalce-210	121	15	(	(	PUNCT
globalce-210	121	16	pma	pma	NOUN
globalce-210	121	17	)	)	PUNCT
globalce-210	121	18	pathways	pathway	NOUN
globalce-210	121	19	for	for	ADP
globalce-210	121	20	samd	samd	NOUN
globalce-210	121	21	.	.	PUNCT
globalce-210	122	1	follows	follow	VERB
globalce-210	122	2	risk	risk	NOUN
globalce-210	122	3	-	-	PUNCT
globalce-210	122	4	based	base	VERB
globalce-210	122	5	classification	classification	NOUN
globalce-210	122	6	similar	similar	ADJ
globalce-210	122	7	to	to	ADP
globalce-210	122	8	the	the	DET
globalce-210	122	9	us	us	PROPN
globalce-210	122	10	fda	fda	PROPN
globalce-210	122	11	.	.	PUNCT
globalce-210	123	1	post	post	ADJ
globalce-210	123	2	-	-	ADJ
globalce-210	123	3	market	market	ADJ
globalce-210	123	4	surveillance	surveillance	NOUN
globalce-210	123	5	requires	require	VERB
globalce-210	123	6	manufacturers	manufacturer	NOUN
globalce-210	123	7	to	to	PART
globalce-210	123	8	have	have	VERB
globalce-210	123	9	a	a	DET
globalce-210	123	10	postmarket	postmarket	ADJ
globalce-210	123	11	surveillance	surveillance	NOUN
globalce-210	123	12	plan	plan	NOUN
globalce-210	123	13	,	,	PUNCT
globalce-210	123	14	potentially	potentially	ADV
globalce-210	123	15	incorporating	incorporate	VERB
globalce-210	123	16	ai	ai	VERB
globalce-210	123	17	for	for	ADP
globalce-210	123	18	anomaly	anomaly	NOUN
globalce-210	123	19	detection	detection	NOUN
globalce-210	123	20	and	and	CCONJ
globalce-210	123	21	trend	trend	NOUN
globalce-210	123	22	analysis.45	analysis.45	ADV
globalce-210	123	23	requires	require	VERB
globalce-210	123	24	manufacturers	manufacturer	NOUN
globalce-210	123	25	to	to	PART
globalce-210	123	26	monitor	monitor	VERB
globalce-210	123	27	and	and	CCONJ
globalce-210	123	28	report	report	VERB
globalce-210	123	29	adverse	adverse	ADJ
globalce-210	123	30	events	event	NOUN
globalce-210	123	31	for	for	ADP
globalce-210	123	32	samd	samd	ADJ
globalce-210	123	33	,	,	PUNCT
globalce-210	123	34	potential	potential	ADJ
globalce-210	123	35	use	use	NOUN
globalce-210	123	36	of	of	ADP
globalce-210	123	37	ai	ai	VERB
globalce-210	123	38	for	for	ADP
globalce-210	123	39	real	real	ADJ
globalce-210	123	40	-	-	PUNCT
globalce-210	123	41	world	world	NOUN
globalce-210	123	42	performance	performance	NOUN
globalce-210	123	43	monitoring	monitoring	NOUN
globalce-210	123	44	.	.	PUNCT
globalce-210	124	1	requires	require	VERB
globalce-210	124	2	manufacturers	manufacturer	NOUN
globalce-210	124	3	to	to	PART
globalce-210	124	4	submit	submit	VERB
globalce-210	124	5	periodic	periodic	ADJ
globalce-210	124	6	safety	safety	NOUN
globalce-210	124	7	update	update	NOUN
globalce-210	124	8	reports	report	NOUN
globalce-210	124	9	(	(	PUNCT
globalce-210	124	10	psurs	psur	NOUN
globalce-210	124	11	)	)	PUNCT
globalce-210	124	12	,	,	PUNCT
globalce-210	124	13	potential	potential	NOUN
globalce-210	124	14	for	for	ADP
globalce-210	124	15	ai	ai	ADV
globalce-210	124	16	-	-	PUNCT
globalce-210	124	17	assisted	assist	VERB
globalce-210	124	18	data	datum	NOUN
globalce-210	124	19	analysis	analysis	NOUN
globalce-210	124	20	.	.	PUNCT
globalce-210	125	1	ai	ai	AUX
globalce-210	125	2	-	-	PUNCT
globalce-210	125	3	specific	specific	ADJ
globalce-210	125	4	requirements	requirement	NOUN
globalce-210	125	5	transparency	transparency	NOUN
globalce-210	125	6	and	and	CCONJ
globalce-210	125	7	explainability	explainability	NOUN
globalce-210	125	8	emphasis	emphasis	NOUN
globalce-210	125	9	on	on	ADP
globalce-210	125	10	transparency	transparency	NOUN
globalce-210	125	11	in	in	ADP
globalce-210	125	12	ai	ai	ADJ
globalce-210	125	13	decision	decision	NOUN
globalce-210	125	14	-	-	PUNCT
globalce-210	125	15	making	make	VERB
globalce-210	125	16	processes	process	NOUN
globalce-210	125	17	and	and	CCONJ
globalce-210	125	18	explainability	explainability	NOUN
globalce-210	125	19	of	of	ADP
globalce-210	125	20	results	result	NOUN
globalce-210	125	21	.	.	PUNCT
globalce-210	126	1	focus	focus	VERB
globalce-210	126	2	on	on	ADP
globalce-210	126	3	good	good	ADJ
globalce-210	126	4	ml	ml	NOUN
globalce-210	126	5	practices	practice	NOUN
globalce-210	126	6	(	(	PUNCT
globalce-210	126	7	gmlp	gmlp	VERB
globalce-210	126	8	)	)	PUNCT
globalce-210	126	9	for	for	ADP
globalce-210	126	10	development	development	NOUN
globalce-210	126	11	and	and	CCONJ
globalce-210	126	12	validation	validation	NOUN
globalce-210	126	13	of	of	ADP
globalce-210	126	14	ai	ai	PROPN
globalce-210	126	15	models	model	NOUN
globalce-210	126	16	.	.	PUNCT
globalce-210	127	1	aligning	align	VERB
globalce-210	127	2	with	with	ADP
globalce-210	127	3	imdrf	imdrf	ADJ
globalce-210	127	4	principles	principle	NOUN
globalce-210	127	5	for	for	ADP
globalce-210	127	6	data	data	NOUN
globalce-210	127	7	access	access	NOUN
globalce-210	127	8	,	,	PUNCT
globalce-210	127	9	security	security	NOUN
globalce-210	127	10	,	,	PUNCT
globalce-210	127	11	and	and	CCONJ
globalce-210	127	12	responsible	responsible	ADJ
globalce-210	127	13	use.45	use.45	ADJ
globalce-210	127	14	change	change	NOUN
globalce-210	127	15	management	management	NOUN
globalce-210	127	16	the	the	DET
globalce-210	127	17	draft	draft	NOUN
globalce-210	127	18	guidance	guidance	NOUN
globalce-210	127	19	highlights	highlight	VERB
globalce-210	127	20	the	the	DET
globalce-210	127	21	necessity	necessity	NOUN
globalce-210	127	22	for	for	ADP
globalce-210	127	23	predefined	predefine	VERB
globalce-210	127	24	change	change	NOUN
globalce-210	127	25	control	control	NOUN
globalce-210	127	26	plans	plan	NOUN
globalce-210	127	27	for	for	ADP
globalce-210	127	28	ai	ai	PROPN
globalce-210	127	29	systems	system	NOUN
globalce-210	127	30	to	to	PART
globalce-210	127	31	maintain	maintain	VERB
globalce-210	127	32	continuous	continuous	ADJ
globalce-210	127	33	regulatory	regulatory	ADJ
globalce-210	127	34	compliance	compliance	NOUN
globalce-210	127	35	.	.	PUNCT
globalce-210	128	1	guidance	guidance	NOUN
globalce-210	128	2	on	on	ADP
globalce-210	128	3	predefined	predefine	VERB
globalce-210	128	4	change	change	NOUN
globalce-210	128	5	control	control	NOUN
globalce-210	128	6	plans	plan	NOUN
globalce-210	128	7	(	(	PUNCT
globalce-210	128	8	pccp	pccp	NOUN
globalce-210	128	9	)	)	PUNCT
globalce-210	128	10	for	for	ADP
globalce-210	128	11	ai	ai	NOUN
globalce-210	128	12	/	/	SYM
globalce-210	128	13	ml	ml	NOUN
globalce-210	128	14	outline	outline	NOUN
globalce-210	128	15	processes	process	NOUN
globalce-210	128	16	for	for	ADP
globalce-210	128	17	managing	manage	VERB
globalce-210	128	18	changes	change	NOUN
globalce-210	128	19	in	in	ADP
globalce-210	128	20	ai	ai	PROPN
globalce-210	128	21	models	model	NOUN
globalce-210	128	22	.	.	PUNCT
globalce-210	129	1	aligns	align	VERB
globalce-210	129	2	with	with	ADP
globalce-210	129	3	imdrf	imdrf	ADJ
globalce-210	129	4	principles	principle	NOUN
globalce-210	129	5	for	for	ADP
globalce-210	129	6	managing	manage	VERB
globalce-210	129	7	changes	change	NOUN
globalce-210	129	8	in	in	ADP
globalce-210	129	9	ai	ai	ADV
globalce-210	129	10	-	-	PUNCT
globalce-210	129	11	based	base	VERB
globalce-210	129	12	medical	medical	ADJ
globalce-210	129	13	devices	device	NOUN
globalce-210	129	14	.	.	PUNCT
globalce-210	130	1	ai	ai	VERB
globalce-210	130	2	advantages	advantage	NOUN
globalce-210	130	3	for	for	ADP
globalce-210	130	4	regulatory	regulatory	ADJ
globalce-210	130	5	bodies	body	NOUN
globalce-210	130	6	efficiency	efficiency	NOUN
globalce-210	130	7	and	and	CCONJ
globalce-210	130	8	monitoring	monitor	VERB
globalce-210	130	9	potential	potential	NOUN
globalce-210	130	10	for	for	SCONJ
globalce-210	130	11	ai	ai	NOUN
globalce-210	130	12	to	to	PART
globalce-210	130	13	improve	improve	VERB
globalce-210	130	14	efficiency	efficiency	NOUN
globalce-210	130	15	in	in	ADP
globalce-210	130	16	monitoring	monitor	VERB
globalce-210	130	17	medical	medical	ADJ
globalce-210	130	18	device	device	NOUN
globalce-210	130	19	performance	performance	NOUN
globalce-210	130	20	and	and	CCONJ
globalce-210	130	21	identifying	identify	VERB
globalce-210	130	22	potential	potential	ADJ
globalce-210	130	23	risks	risk	NOUN
globalce-210	130	24	.	.	PUNCT
globalce-210	131	1	potential	potential	NOUN
globalce-210	131	2	for	for	ADP
globalce-210	131	3	ai	ai	VERB
globalce-210	131	4	to	to	PART
globalce-210	131	5	streamline	streamline	VERB
globalce-210	131	6	data	datum	NOUN
globalce-210	131	7	analysis	analysis	NOUN
globalce-210	131	8	and	and	CCONJ
globalce-210	131	9	automate	automate	ADJ
globalce-210	131	10	risk	risk	NOUN
globalce-210	131	11	assessment	assessment	NOUN
globalce-210	131	12	processes	process	NOUN
globalce-210	131	13	for	for	ADP
globalce-210	131	14	samd	samd	ADJ
globalce-210	131	15	.	.	PUNCT
globalce-210	132	1	potential	potential	NOUN
globalce-210	132	2	for	for	ADP
globalce-210	132	3	aiassisted	aiassiste	VERB
globalce-210	132	4	automation	automation	NOUN
globalce-210	132	5	in	in	ADP
globalce-210	132	6	regulatory	regulatory	ADJ
globalce-210	132	7	processes	process	NOUN
globalce-210	132	8	once	once	SCONJ
globalce-210	132	9	frameworks	framework	NOUN
globalce-210	132	10	are	be	AUX
globalce-210	132	11	established	establish	VERB
globalce-210	132	12	.	.	PUNCT
globalce-210	133	1	challenges	challenge	VERB
globalce-210	133	2	regulatory	regulatory	ADJ
globalce-210	133	3	uncertainty	uncertainty	NOUN
globalce-210	133	4	lack	lack	NOUN
globalce-210	133	5	of	of	ADP
globalce-210	133	6	clear	clear	ADJ
globalce-210	133	7	and	and	CCONJ
globalce-210	133	8	finalized	finalized	ADJ
globalce-210	133	9	regulations	regulation	NOUN
globalce-210	133	10	for	for	ADP
globalce-210	133	11	ai	ai	NOUN
globalce-210	133	12	in	in	ADP
globalce-210	133	13	medical	medical	ADJ
globalce-210	133	14	devices	device	NOUN
globalce-210	133	15	creates	create	VERB
globalce-210	133	16	uncertainty	uncertainty	NOUN
globalce-210	133	17	for	for	ADP
globalce-210	133	18	developers	developer	NOUN
globalce-210	133	19	and	and	CCONJ
globalce-210	133	20	regulators.46	regulators.46	NOUN
globalce-210	133	21	adapting	adapt	VERB
globalce-210	133	22	existing	exist	VERB
globalce-210	133	23	frameworks	framework	NOUN
globalce-210	133	24	to	to	PART
globalce-210	133	25	address	address	VERB
globalce-210	133	26	the	the	DET
globalce-210	133	27	continuous	continuous	ADJ
globalce-210	133	28	learning	learning	NOUN
globalce-210	133	29	nature	nature	NOUN
globalce-210	133	30	of	of	ADP
globalce-210	133	31	ai	ai	PROPN
globalce-210	133	32	models	model	NOUN
globalce-210	133	33	presents	present	VERB
globalce-210	133	34	challenges.47	challenges.47	NOUN
globalce-210	133	35	limited	limited	ADJ
globalce-210	133	36	experience	experience	NOUN
globalce-210	133	37	and	and	CCONJ
globalce-210	133	38	resources	resource	NOUN
globalce-210	133	39	for	for	ADP
globalce-210	133	40	implementing	implement	VERB
globalce-210	133	41	ai	ai	NOUN
globalce-210	133	42	-	-	PUNCT
globalce-210	133	43	based	base	VERB
globalce-210	133	44	regulatory	regulatory	ADJ
globalce-210	133	45	processes.48	processes.48	PROPN
globalce-210	133	46	19	19	NUM
globalce-210	133	47	j	j	PROPN
globalce-210	133	48	global	global	ADJ
globalce-210	133	49	clinical	clinical	ADJ
globalce-210	133	50	engineering	engineering	NOUN
globalce-210	133	51	vol.7	vol.7	PROPN
globalce-210	133	52	issue	issue	NOUN
globalce-210	133	53	2	2	NUM
globalce-210	133	54	:	:	SYM
globalce-210	133	55	2025	2025	NUM
globalce-210	133	56	gaur	gaur	NOUN
globalce-210	133	57	,	,	PUNCT
globalce-210	133	58	akram	akram	PROPN
globalce-210	133	59	,	,	PUNCT
globalce-210	133	60	singh	singh	PROPN
globalce-210	133	61	,	,	PUNCT
globalce-210	133	62	chauhan	chauhan	PROPN
globalce-210	133	63	:	:	PUNCT
globalce-210	133	64	artificial	artificial	ADJ
globalce-210	133	65	intelligence	intelligence	NOUN
globalce-210	133	66	-	-	PUNCT
globalce-210	133	67	driven	drive	VERB
globalce-210	133	68	insights	insight	NOUN
globalce-210	133	69	for	for	ADP
globalce-210	133	70	regulatory	regulatory	ADJ
globalce-210	133	71	intelligence	intelligence	NOUN
globalce-210	133	72	in	in	ADP
globalce-210	133	73	medical	medical	ADJ
globalce-210	133	74	devices	device	NOUN
globalce-210	133	75	:	:	PUNCT
globalce-210	133	76	evaluating	evaluate	VERB
globalce-210	133	77	ema	ema	PROPN
globalce-210	133	78	,	,	PUNCT
globalce-210	133	79	fda	fda	PROPN
globalce-210	133	80	,	,	PUNCT
globalce-210	133	81	and	and	CCONJ
globalce-210	133	82	cdsco	cdsco	NOUN
globalce-210	133	83	frameworks	framework	NOUN
globalce-210	133	84	standards	standard	NOUN
globalce-210	133	85	that	that	PRON
globalce-210	133	86	are	be	AUX
globalce-210	133	87	the	the	DET
globalce-210	133	88	same	same	ADJ
globalce-210	133	89	everywhere	everywhere	ADV
globalce-210	133	90	:	:	PUNCT
globalce-210	133	91	in	in	ADP
globalce-210	133	92	india	india	PROPN
globalce-210	133	93	,	,	PUNCT
globalce-210	133	94	samds	samds	NOUN
globalce-210	133	95	must	must	AUX
globalce-210	133	96	follow	follow	VERB
globalce-210	133	97	international	international	ADJ
globalce-210	133	98	rules	rule	NOUN
globalce-210	133	99	,	,	PUNCT
globalce-210	133	100	such	such	ADJ
globalce-210	133	101	as	as	ADP
globalce-210	133	102	iec	iec	PROPN
globalce-210	133	103	62304	62304	NUM
globalce-210	133	104	for	for	ADP
globalce-210	133	105	software	software	NOUN
globalce-210	133	106	lifecycle	lifecycle	NOUN
globalce-210	133	107	,	,	PUNCT
globalce-210	133	108	iec	iec	PROPN
globalce-210	133	109	60601	60601	NUM
globalce-210	133	110	-	-	SYM
globalce-210	133	111	1	1	NUM
globalce-210	133	112	for	for	ADP
globalce-210	133	113	embedded	embed	VERB
globalce-210	133	114	software	software	NOUN
globalce-210	133	115	,	,	PUNCT
globalce-210	133	116	and	and	CCONJ
globalce-210	133	117	iec	iec	NOUN
globalce-210	133	118	82304	82304	NUM
globalce-210	133	119	-	-	SYM
globalce-210	133	120	1	1	NUM
globalce-210	133	121	for	for	ADP
globalce-210	133	122	standalone	standalone	NOUN
globalce-210	133	123	samds.42	samds.42	NOUN
globalce-210	133	124	table	table	NOUN
globalce-210	133	125	1	1	NUM
globalce-210	133	126	provides	provide	VERB
globalce-210	133	127	a	a	DET
globalce-210	133	128	comparative	comparative	ADJ
globalce-210	133	129	analysis	analysis	NOUN
globalce-210	133	130	of	of	ADP
globalce-210	133	131	the	the	DET
globalce-210	133	132	regulatory	regulatory	ADJ
globalce-210	133	133	frameworks	framework	NOUN
globalce-210	133	134	for	for	ADP
globalce-210	133	135	ai	ai	VERB
globalce-210	133	136	across	across	ADP
globalce-210	133	137	various	various	ADJ
globalce-210	133	138	regulatory	regulatory	ADJ
globalce-210	133	139	agencies	agency	NOUN
globalce-210	133	140	,	,	PUNCT
globalce-210	133	141	highlighting	highlight	VERB
globalce-210	133	142	key	key	ADJ
globalce-210	133	143	similarities	similarity	NOUN
globalce-210	133	144	and	and	CCONJ
globalce-210	133	145	differences	difference	NOUN
globalce-210	133	146	in	in	ADP
globalce-210	133	147	their	their	PRON
globalce-210	133	148	approaches	approach	NOUN
globalce-210	133	149	.	.	PUNCT
globalce-210	134	1	possible	possible	ADJ
globalce-210	134	2	inclusion	inclusion	NOUN
globalce-210	134	3	and	and	CCONJ
globalce-210	134	4	advancement	advancement	NOUN
globalce-210	134	5	artificial	artificial	ADJ
globalce-210	134	6	intelligence	intelligence	NOUN
globalce-210	134	7	and	and	CCONJ
globalce-210	134	8	innovative	innovative	ADJ
globalce-210	134	9	regulatory	regulatory	ADJ
globalce-210	134	10	intelligence	intelligence	NOUN
globalce-210	134	11	integration	integration	NOUN
globalce-210	134	12	with	with	ADP
globalce-210	134	13	medical	medical	ADJ
globalce-210	134	14	devices	device	NOUN
globalce-210	134	15	are	be	AUX
globalce-210	134	16	to	to	PART
globalce-210	134	17	revolutionize	revolutionize	VERB
globalce-210	134	18	efficiency	efficiency	NOUN
globalce-210	134	19	,	,	PUNCT
globalce-210	134	20	accuracy	accuracy	NOUN
globalce-210	134	21	,	,	PUNCT
globalce-210	134	22	and	and	CCONJ
globalce-210	134	23	compliance	compliance	NOUN
globalce-210	134	24	.	.	PUNCT
globalce-210	135	1	the	the	DET
globalce-210	135	2	changing	change	VERB
globalce-210	135	3	landscape	landscape	NOUN
globalce-210	135	4	of	of	ADP
globalce-210	135	5	the	the	DET
globalce-210	135	6	medical	medical	ADJ
globalce-210	135	7	device	device	NOUN
globalce-210	135	8	regulatory	regulatory	ADJ
globalce-210	135	9	framework	framework	NOUN
globalce-210	135	10	is	be	AUX
globalce-210	135	11	driven	drive	VERB
globalce-210	135	12	by	by	ADP
globalce-210	135	13	the	the	DET
globalce-210	135	14	growth	growth	NOUN
globalce-210	135	15	in	in	ADP
globalce-210	135	16	ai	ai	PROPN
globalce-210	135	17	solutions	solution	NOUN
globalce-210	135	18	,	,	PUNCT
globalce-210	135	19	which	which	PRON
globalce-210	135	20	are	be	AUX
globalce-210	135	21	now	now	ADV
globalce-210	135	22	utilized	utilize	VERB
globalce-210	135	23	by	by	ADP
globalce-210	135	24	prominent	prominent	ADJ
globalce-210	135	25	regulators	regulator	NOUN
globalce-210	135	26	,	,	PUNCT
globalce-210	135	27	such	such	ADJ
globalce-210	135	28	as	as	ADP
globalce-210	135	29	the	the	DET
globalce-210	135	30	ema	ema	PROPN
globalce-210	135	31	,	,	PUNCT
globalce-210	135	32	fda	fda	PROPN
globalce-210	135	33	,	,	PUNCT
globalce-210	135	34	and	and	CCONJ
globalce-210	135	35	cdsco	cdsco	PROPN
globalce-210	135	36	.	.	PUNCT
globalce-210	136	1	this	this	DET
globalce-210	136	2	section	section	NOUN
globalce-210	136	3	discusses	discuss	VERB
globalce-210	136	4	potential	potential	ADJ
globalce-210	136	5	progress	progress	NOUN
globalce-210	136	6	and	and	CCONJ
globalce-210	136	7	distinct	distinct	ADJ
globalce-210	136	8	types	type	NOUN
globalce-210	136	9	of	of	ADP
globalce-210	136	10	innovation	innovation	NOUN
globalce-210	136	11	that	that	PRON
globalce-210	136	12	are	be	AUX
globalce-210	136	13	tailored	tailor	VERB
globalce-210	136	14	to	to	ADP
globalce-210	136	15	each	each	DET
globalce-210	136	16	regulator	regulator	NOUN
globalce-210	136	17	’s	’s	PART
globalce-210	136	18	specific	specific	ADJ
globalce-210	136	19	issues	issue	NOUN
globalce-210	136	20	.	.	PUNCT
globalce-210	137	1	focus	focus	NOUN
globalce-210	137	2	areas	area	NOUN
globalce-210	137	3	include	include	VERB
globalce-210	137	4	better	well	ADJ
globalce-210	137	5	data	datum	NOUN
globalce-210	137	6	integration	integration	NOUN
globalce-210	137	7	and	and	CCONJ
globalce-210	137	8	interoperability	interoperability	NOUN
globalce-210	137	9	,	,	PUNCT
globalce-210	137	10	regulator	regulator	NOUN
globalce-210	137	11	-	-	PUNCT
globalce-210	137	12	specific	specific	ADJ
globalce-210	137	13	ai	ai	NOUN
globalce-210	137	14	applications	application	NOUN
globalce-210	137	15	via	via	ADP
globalce-210	137	16	innovation	innovation	NOUN
globalce-210	137	17	,	,	PUNCT
globalce-210	137	18	and	and	CCONJ
globalce-210	137	19	an	an	DET
globalce-210	137	20	ethical	ethical	ADJ
globalce-210	137	21	and	and	CCONJ
globalce-210	137	22	transparent	transparent	ADJ
globalce-210	137	23	framework	framework	NOUN
globalce-210	137	24	for	for	ADP
globalce-210	137	25	ai	ai	PROPN
globalce-210	137	26	development	development	NOUN
globalce-210	137	27	.	.	PUNCT
globalce-210	138	1	the	the	DET
globalce-210	138	2	purpose	purpose	NOUN
globalce-210	138	3	is	be	AUX
globalce-210	138	4	to	to	PART
globalce-210	138	5	present	present	VERB
globalce-210	138	6	ai	ai	VERB
globalce-210	138	7	’s	’s	ADV
globalce-210	138	8	critical	critical	ADJ
globalce-210	138	9	and	and	CCONJ
globalce-210	138	10	ever	ever	ADV
globalce-210	138	11	-	-	PUNCT
globalce-210	138	12	growing	grow	VERB
globalce-210	138	13	role	role	NOUN
globalce-210	138	14	in	in	ADP
globalce-210	138	15	achieving	achieve	VERB
globalce-210	138	16	better	well	ADJ
globalce-210	138	17	regulation	regulation	NOUN
globalce-210	138	18	,	,	PUNCT
globalce-210	138	19	patient	patient	ADJ
globalce-210	138	20	safety	safety	NOUN
globalce-210	138	21	,	,	PUNCT
globalce-210	138	22	and	and	CCONJ
globalce-210	138	23	true	true	ADJ
globalce-210	138	24	international	international	ADJ
globalce-210	138	25	alignment	alignment	NOUN
globalce-210	138	26	.	.	PUNCT
globalce-210	139	1	enhanced	enhance	VERB
globalce-210	139	2	data	data	NOUN
globalce-210	139	3	integration	integration	NOUN
globalce-210	139	4	and	and	CCONJ
globalce-210	139	5	interoperability	interoperability	NOUN
globalce-210	139	6	when	when	SCONJ
globalce-210	139	7	it	it	PRON
globalce-210	139	8	comes	come	VERB
globalce-210	139	9	to	to	ADP
globalce-210	139	10	regulating	regulate	VERB
globalce-210	139	11	medical	medical	ADJ
globalce-210	139	12	devices	device	NOUN
globalce-210	139	13	,	,	PUNCT
globalce-210	139	14	it	it	PRON
globalce-210	139	15	’s	’	VERB
globalce-210	139	16	very	very	ADV
globalce-210	139	17	important	important	ADJ
globalce-210	139	18	to	to	PART
globalce-210	139	19	combine	combine	VERB
globalce-210	139	20	data	datum	NOUN
globalce-210	139	21	from	from	ADP
globalce-210	139	22	different	different	ADJ
globalce-210	139	23	sources	source	NOUN
globalce-210	139	24	,	,	PUNCT
globalce-210	139	25	such	such	ADJ
globalce-210	139	26	as	as	ADP
globalce-210	139	27	clinical	clinical	ADJ
globalce-210	139	28	trials	trial	NOUN
globalce-210	139	29	,	,	PUNCT
globalce-210	139	30	post	post	ADJ
globalce-210	139	31	-	-	ADJ
globalce-210	139	32	market	market	ADJ
globalce-210	139	33	surveillance	surveillance	NOUN
globalce-210	139	34	,	,	PUNCT
globalce-210	139	35	and	and	CCONJ
globalce-210	139	36	ehrs	ehr	VERB
globalce-210	139	37	.	.	PUNCT
globalce-210	140	1	this	this	PRON
globalce-210	140	2	is	be	AUX
globalce-210	140	3	because	because	SCONJ
globalce-210	140	4	these	these	DET
globalce-210	140	5	sources	source	NOUN
globalce-210	140	6	provide	provide	VERB
globalce-210	140	7	important	important	ADJ
globalce-210	140	8	information	information	NOUN
globalce-210	140	9	for	for	ADP
globalce-210	140	10	making	make	VERB
globalce-210	140	11	sure	sure	ADJ
globalce-210	140	12	that	that	SCONJ
globalce-210	140	13	all	all	DET
globalce-210	140	14	regulations	regulation	NOUN
globalce-210	140	15	are	be	AUX
globalce-210	140	16	followed	follow	VERB
globalce-210	140	17	.	.	PUNCT
globalce-210	141	1	in	in	ADP
globalce-210	141	2	response	response	NOUN
globalce-210	141	3	to	to	ADP
globalce-210	141	4	this	this	DET
globalce-210	141	5	need	need	NOUN
globalce-210	141	6	,	,	PUNCT
globalce-210	141	7	ai	ai	VERB
globalce-210	141	8	algorithms	algorithm	NOUN
globalce-210	141	9	are	be	AUX
globalce-210	141	10	created	create	VERB
globalce-210	141	11	that	that	PRON
globalce-210	141	12	allow	allow	VERB
globalce-210	141	13	huge	huge	ADJ
globalce-210	141	14	amounts	amount	NOUN
globalce-210	141	15	of	of	ADP
globalce-210	141	16	unstructured	unstructured	ADJ
globalce-210	141	17	data	datum	NOUN
globalce-210	141	18	from	from	ADP
globalce-210	141	19	many	many	ADJ
globalce-210	141	20	systems	system	NOUN
globalce-210	141	21	to	to	PART
globalce-210	141	22	be	be	AUX
globalce-210	141	23	collected	collect	VERB
globalce-210	141	24	,	,	PUNCT
globalce-210	141	25	processed	process	VERB
globalce-210	141	26	,	,	PUNCT
globalce-210	141	27	and	and	CCONJ
globalce-210	141	28	turned	turn	VERB
globalce-210	141	29	into	into	ADP
globalce-210	141	30	useful	useful	ADJ
globalce-210	141	31	information	information	NOUN
globalce-210	141	32	.	.	PUNCT
globalce-210	142	1	these	these	DET
globalce-210	142	2	algorithms	algorithm	NOUN
globalce-210	142	3	can	can	AUX
globalce-210	142	4	extract	extract	VERB
globalce-210	142	5	and	and	CCONJ
globalce-210	142	6	align	align	VERB
globalce-210	142	7	large	large	ADJ
globalce-210	142	8	amounts	amount	NOUN
globalce-210	142	9	of	of	ADP
globalce-210	142	10	data	datum	NOUN
globalce-210	142	11	in	in	ADP
globalce-210	142	12	real	real	ADJ
globalce-210	142	13	time	time	NOUN
globalce-210	142	14	,	,	PUNCT
globalce-210	142	15	while	while	SCONJ
globalce-210	142	16	most	most	ADJ
globalce-210	142	17	other	other	ADJ
globalce-210	142	18	ways	way	NOUN
globalce-210	142	19	of	of	ADP
globalce-210	142	20	integrating	integrate	VERB
globalce-210	142	21	data	datum	NOUN
globalce-210	142	22	are	be	AUX
globalce-210	142	23	done	do	VERB
globalce-210	142	24	manually.49	manually.49	PROPN
globalce-210	142	25	one	one	NUM
globalce-210	142	26	example	example	NOUN
globalce-210	142	27	of	of	ADP
globalce-210	142	28	this	this	DET
globalce-210	142	29	trend	trend	NOUN
globalce-210	142	30	is	be	AUX
globalce-210	142	31	the	the	DET
globalce-210	142	32	use	use	NOUN
globalce-210	142	33	of	of	ADP
globalce-210	142	34	ml	ml	NOUN
globalce-210	142	35	models	model	NOUN
globalce-210	142	36	to	to	PART
globalce-210	142	37	connect	connect	VERB
globalce-210	142	38	patterns	pattern	NOUN
globalce-210	142	39	and	and	CCONJ
globalce-210	142	40	changes	change	NOUN
globalce-210	142	41	in	in	ADP
globalce-210	142	42	different	different	ADJ
globalce-210	142	43	databases	database	NOUN
globalce-210	142	44	.	.	PUNCT
globalce-210	143	1	this	this	PRON
globalce-210	143	2	allows	allow	VERB
globalce-210	143	3	regulators	regulator	NOUN
globalce-210	143	4	to	to	PART
globalce-210	143	5	see	see	VERB
globalce-210	143	6	how	how	SCONJ
globalce-210	143	7	the	the	DET
globalce-210	143	8	device	device	NOUN
globalce-210	143	9	works	work	VERB
globalce-210	143	10	in	in	ADP
globalce-210	143	11	a	a	DET
globalce-210	143	12	bigger	big	ADJ
globalce-210	143	13	picture	picture	NOUN
globalce-210	143	14	for	for	ADP
globalce-210	143	15	safety	safety	NOUN
globalce-210	143	16	reasons	reason	NOUN
globalce-210	143	17	.	.	PUNCT
globalce-210	144	1	also	also	ADV
globalce-210	144	2	,	,	PUNCT
globalce-210	144	3	it	it	PRON
globalce-210	144	4	’s	’	VERB
globalce-210	144	5	faster	fast	ADV
globalce-210	144	6	to	to	PART
globalce-210	144	7	share	share	VERB
globalce-210	144	8	data	datum	NOUN
globalce-210	144	9	with	with	ADP
globalce-210	144	10	regulatory	regulatory	ADJ
globalce-210	144	11	bodies	body	NOUN
globalce-210	144	12	and	and	CCONJ
globalce-210	144	13	other	other	ADJ
globalce-210	144	14	important	important	ADJ
globalce-210	144	15	parties	party	NOUN
globalce-210	144	16	,	,	PUNCT
globalce-210	144	17	thanks	thank	NOUN
globalce-210	144	18	to	to	ADP
globalce-210	144	19	the	the	DET
globalce-210	144	20	progress	progress	NOUN
globalce-210	144	21	in	in	ADP
globalce-210	144	22	standardizing	standardize	VERB
globalce-210	144	23	and	and	CCONJ
globalce-210	144	24	connecting	connect	VERB
globalce-210	144	25	data	datum	NOUN
globalce-210	144	26	.	.	PUNCT
globalce-210	145	1	health	health	NOUN
globalce-210	145	2	level	level	NOUN
globalce-210	145	3	seven	seven	NUM
globalce-210	145	4	international	international	ADJ
globalce-210	145	5	(	(	PUNCT
globalce-210	145	6	hl7	hl7	NOUN
globalce-210	145	7	)	)	PUNCT
globalce-210	145	8	standards	standard	NOUN
globalce-210	145	9	or	or	CCONJ
globalce-210	145	10	fast	fast	ADJ
globalce-210	145	11	healthcare	healthcare	NOUN
globalce-210	145	12	interoperability	interoperability	NOUN
globalce-210	145	13	resources	resource	NOUN
globalce-210	145	14	(	(	PUNCT
globalce-210	145	15	fhir	fhir	NOUN
globalce-210	145	16	)	)	PUNCT
globalce-210	145	17	are	be	AUX
globalce-210	145	18	examples	example	NOUN
globalce-210	145	19	of	of	ADP
globalce-210	145	20	universal	universal	ADJ
globalce-210	145	21	data	datum	NOUN
globalce-210	145	22	standards	standard	NOUN
globalce-210	145	23	and	and	CCONJ
globalce-210	145	24	protocols	protocol	NOUN
globalce-210	145	25	that	that	PRON
globalce-210	145	26	make	make	VERB
globalce-210	145	27	sure	sure	ADJ
globalce-210	145	28	that	that	SCONJ
globalce-210	145	29	different	different	ADJ
globalce-210	145	30	systems	system	NOUN
globalce-210	145	31	talk	talk	VERB
globalce-210	145	32	to	to	ADP
globalce-210	145	33	each	each	DET
globalce-210	145	34	other	other	ADJ
globalce-210	145	35	correctly	correctly	ADV
globalce-210	145	36	so	so	SCONJ
globalce-210	145	37	that	that	SCONJ
globalce-210	145	38	data	datum	NOUN
globalce-210	145	39	are	be	AUX
globalce-210	145	40	used	use	VERB
globalce-210	145	41	.	.	PUNCT
globalce-210	146	1	not	not	PART
globalce-210	146	2	only	only	ADV
globalce-210	146	3	do	do	AUX
globalce-210	146	4	these	these	DET
globalce-210	146	5	improvements	improvement	NOUN
globalce-210	146	6	speed	speed	VERB
globalce-210	146	7	up	up	ADP
globalce-210	146	8	the	the	DET
globalce-210	146	9	regulatory	regulatory	ADJ
globalce-210	146	10	process	process	NOUN
globalce-210	146	11	,	,	PUNCT
globalce-210	146	12	but	but	CCONJ
globalce-210	146	13	they	they	PRON
globalce-210	146	14	also	also	ADV
globalce-210	146	15	make	make	VERB
globalce-210	146	16	it	it	PRON
globalce-210	146	17	easier	easy	ADJ
globalce-210	146	18	to	to	PART
globalce-210	146	19	spot	spot	VERB
globalce-210	146	20	and	and	CCONJ
globalce-210	146	21	act	act	VERB
globalce-210	146	22	on	on	ADP
globalce-210	146	23	safety	safety	NOUN
globalce-210	146	24	signals	signal	NOUN
globalce-210	146	25	quickly	quickly	ADV
globalce-210	146	26	.	.	PUNCT
globalce-210	147	1	data	datum	NOUN
globalce-210	147	2	integration	integration	NOUN
globalce-210	147	3	and	and	CCONJ
globalce-210	147	4	interoperability	interoperability	NOUN
globalce-210	147	5	made	make	VERB
globalce-210	147	6	possible	possible	ADJ
globalce-210	147	7	by	by	ADP
globalce-210	147	8	ai	ai	INTJ
globalce-210	147	9	help	help	NOUN
globalce-210	147	10	regulatory	regulatory	ADJ
globalce-210	147	11	agencies	agency	NOUN
globalce-210	147	12	make	make	VERB
globalce-210	147	13	smarter	smart	ADJ
globalce-210	147	14	rules	rule	NOUN
globalce-210	147	15	to	to	PART
globalce-210	147	16	protect	protect	VERB
globalce-210	147	17	patients	patient	NOUN
globalce-210	147	18	and	and	CCONJ
globalce-210	147	19	keep	keep	VERB
globalce-210	147	20	up	up	ADP
globalce-210	147	21	with	with	ADP
globalce-210	147	22	medtech	medtech	NOUN
globalce-210	147	23	innovation.49	innovation.49	ADJ
globalce-210	147	24	regulatory	regulatory	ADJ
globalce-210	147	25	body	body	NOUN
globalce-210	147	26	-	-	PUNCT
globalce-210	147	27	specific	specific	ADJ
globalce-210	147	28	ai	ai	NOUN
globalce-210	147	29	innovations	innovation	NOUN
globalce-210	147	30	customization	customization	NOUN
globalce-210	147	31	of	of	ADP
globalce-210	147	32	ai	ai	ADJ
globalce-210	147	33	solutions	solution	NOUN
globalce-210	147	34	to	to	PART
globalce-210	147	35	tailor	tailor	VERB
globalce-210	147	36	specific	specific	ADJ
globalce-210	147	37	regulatory	regulatory	ADJ
globalce-210	147	38	challenges	challenge	NOUN
globalce-210	147	39	encountered	encounter	VERB
globalce-210	147	40	by	by	ADP
globalce-210	147	41	ema	ema	PROPN
globalce-210	147	42	,	,	PUNCT
globalce-210	147	43	fda	fda	PROPN
globalce-210	147	44	,	,	PUNCT
globalce-210	147	45	and	and	CCONJ
globalce-210	147	46	cdsco	cdsco	PROPN
globalce-210	147	47	is	be	AUX
globalce-210	147	48	critical	critical	ADJ
globalce-210	147	49	in	in	ADP
globalce-210	147	50	streamlining	streamline	VERB
globalce-210	147	51	regulatory	regulatory	ADJ
globalce-210	147	52	operations	operation	NOUN
globalce-210	147	53	and	and	CCONJ
globalce-210	147	54	maintaining	maintain	VERB
globalce-210	147	55	compliance	compliance	NOUN
globalce-210	147	56	acts	act	NOUN
globalce-210	147	57	.	.	PUNCT
globalce-210	148	1	every	every	DET
globalce-210	148	2	regulatory	regulatory	ADJ
globalce-210	148	3	body	body	NOUN
globalce-210	148	4	works	work	VERB
globalce-210	148	5	within	within	ADP
globalce-210	148	6	different	different	ADJ
globalce-210	148	7	laws	law	NOUN
globalce-210	148	8	and	and	CCONJ
globalce-210	148	9	healthcare	healthcare	NOUN
globalce-210	148	10	contexts	context	NOUN
globalce-210	148	11	,	,	PUNCT
globalce-210	148	12	calling	call	VERB
globalce-210	148	13	for	for	ADP
globalce-210	148	14	highly	highly	ADV
globalce-210	148	15	differentiated	differentiated	ADJ
globalce-210	148	16	ai	ai	NOUN
globalce-210	148	17	use	use	NOUN
globalce-210	148	18	cases	case	NOUN
globalce-210	148	19	that	that	PRON
globalce-210	148	20	answer	answer	VERB
globalce-210	148	21	to	to	ADP
globalce-210	148	22	individualized	individualized	ADJ
globalce-210	148	23	requirements	requirement	NOUN
globalce-210	148	24	.	.	PUNCT
globalce-210	149	1	the	the	DET
globalce-210	149	2	ema	ema	PROPN
globalce-210	149	3	,	,	PUNCT
globalce-210	149	4	for	for	ADP
globalce-210	149	5	example	example	NOUN
globalce-210	149	6	,	,	PUNCT
globalce-210	149	7	has	have	AUX
globalce-210	149	8	been	be	AUX
globalce-210	149	9	using	use	VERB
globalce-210	149	10	ai	ai	VERB
globalce-210	149	11	to	to	PART
globalce-210	149	12	facilitate	facilitate	VERB
globalce-210	149	13	the	the	DET
globalce-210	149	14	review	review	NOUN
globalce-210	149	15	of	of	ADP
globalce-210	149	16	clinical	clinical	ADJ
globalce-210	149	17	trial	trial	NOUN
globalce-210	149	18	data	datum	NOUN
globalce-210	149	19	processing	processing	NOUN
globalce-210	149	20	validations	validation	NOUN
globalce-210	149	21	with	with	ADP
globalce-210	149	22	a	a	DET
globalce-210	149	23	view	view	NOUN
globalce-210	149	24	to	to	ADP
globalce-210	149	25	speeding	speed	VERB
globalce-210	149	26	up	up	ADP
globalce-210	149	27	the	the	DET
globalce-210	149	28	approval	approval	NOUN
globalce-210	149	29	process	process	NOUN
globalce-210	149	30	swiftly	swiftly	ADV
globalce-210	149	31	and	and	CCONJ
globalce-210	149	32	accurately	accurately	ADV
globalce-210	149	33	while	while	SCONJ
globalce-210	149	34	maintaining	maintain	VERB
globalce-210	149	35	significant	significant	ADJ
globalce-210	149	36	safety	safety	NOUN
globalce-210	149	37	assessments.49	assessments.49	NOUN
globalce-210	149	38	through	through	ADP
globalce-210	149	39	real	real	ADJ
globalce-210	149	40	-	-	PUNCT
globalce-210	149	41	time	time	NOUN
globalce-210	149	42	post	post	ADJ
globalce-210	149	43	-	-	ADJ
globalce-210	149	44	market	market	ADJ
globalce-210	149	45	surveillance	surveillance	NOUN
globalce-210	149	46	,	,	PUNCT
globalce-210	149	47	the	the	DET
globalce-210	149	48	fda	fda	PROPN
globalce-210	149	49	has	have	AUX
globalce-210	149	50	led	lead	VERB
globalce-210	149	51	the	the	DET
globalce-210	149	52	way	way	NOUN
globalce-210	149	53	in	in	ADP
globalce-210	149	54	its	its	PRON
globalce-210	149	55	application	application	NOUN
globalce-210	149	56	of	of	ADP
globalce-210	149	57	ml	ml	ADP
globalce-210	149	58	algorithms	algorithm	NOUN
globalce-210	149	59	and	and	CCONJ
globalce-210	149	60	other	other	ADJ
globalce-210	149	61	ai	ai	PROPN
globalce-210	149	62	technologies	technology	NOUN
globalce-210	149	63	to	to	PART
globalce-210	149	64	track	track	VERB
globalce-210	149	65	adverse	adverse	ADJ
globalce-210	149	66	event	event	NOUN
globalce-210	149	67	data	datum	NOUN
globalce-210	149	68	(	(	PUNCT
globalce-210	149	69	and	and	CCONJ
globalce-210	149	70	even	even	ADV
globalce-210	149	71	device	device	NOUN
globalce-210	149	72	performance	performance	NOUN
globalce-210	149	73	)	)	PUNCT
globalce-210	149	74	continuously	continuously	ADV
globalce-210	149	75	.	.	PUNCT
globalce-210	150	1	in	in	ADP
globalce-210	150	2	india	india	PROPN
globalce-210	150	3	,	,	PUNCT
globalce-210	150	4	the	the	DET
globalce-210	150	5	cdsco	cdsco	PROPN
globalce-210	150	6	is	be	AUX
globalce-210	150	7	turning	turn	VERB
globalce-210	150	8	to	to	AUX
globalce-210	150	9	ai	ai	VERB
globalce-210	150	10	-	-	PUNCT
globalce-210	150	11	powered	power	VERB
globalce-210	150	12	ml	ml	NOUN
globalce-210	150	13	tools	tool	NOUN
globalce-210	150	14	that	that	PRON
globalce-210	150	15	can	can	AUX
globalce-210	150	16	help	help	VERB
globalce-210	150	17	improve	improve	VERB
globalce-210	150	18	regulatory	regulatory	ADJ
globalce-210	150	19	submission	submission	NOUN
globalce-210	150	20	and	and	CCONJ
globalce-210	150	21	approval	approval	NOUN
globalce-210	150	22	time	time	NOUN
globalce-210	150	23	with	with	ADP
globalce-210	150	24	so	so	ADV
globalce-210	150	25	many	many	ADJ
globalce-210	150	26	medical	medical	ADJ
globalce-210	150	27	devices	device	NOUN
globalce-210	150	28	entering	enter	VERB
globalce-210	150	29	a	a	DET
globalce-210	150	30	diverse	diverse	ADJ
globalce-210	150	31	market	market	NOUN
globalce-210	150	32	rapidly.49	rapidly.49	ADP
globalce-210	150	33	these	these	PRON
globalce-210	150	34	customized	customize	VERB
globalce-210	150	35	ai	ai	VERB
globalce-210	150	36	solutions	solution	NOUN
globalce-210	150	37	have	have	AUX
globalce-210	150	38	seen	see	VERB
globalce-210	150	39	a	a	DET
globalce-210	150	40	level	level	NOUN
globalce-210	150	41	of	of	ADP
globalce-210	150	42	advancements	advancement	NOUN
globalce-210	150	43	proven	prove	VERB
globalce-210	150	44	by	by	ADP
globalce-210	150	45	successful	successful	ADJ
globalce-210	150	46	implementation	implementation	NOUN
globalce-210	150	47	by	by	ADP
globalce-210	150	48	regulatory	regulatory	ADJ
globalce-210	150	49	bodies	body	NOUN
globalce-210	150	50	.	.	PUNCT
globalce-210	151	1	the	the	DET
globalce-210	151	2	fda	fda	PROPN
globalce-210	151	3	’s	’s	PART
globalce-210	151	4	sentinel	sentinel	ADJ
globalce-210	151	5	initiative	initiative	NOUN
globalce-210	151	6	alone	alone	ADV
globalce-210	151	7	is	be	AUX
globalce-210	151	8	a	a	DET
globalce-210	151	9	case	case	NOUN
globalce-210	151	10	of	of	ADP
globalce-210	151	11	how	how	SCONJ
globalce-210	151	12	large	large	ADJ
globalce-210	151	13	-	-	PUNCT
globalce-210	151	14	scale	scale	NOUN
globalce-210	151	15	healthcare	healthcare	NOUN
globalce-210	151	16	data	datum	NOUN
globalce-210	151	17	are	be	AUX
globalce-210	151	18	analyzed	analyze	VERB
globalce-210	151	19	for	for	ADP
globalce-210	151	20	post	post	ADJ
globalce-210	151	21	-	-	ADJ
globalce-210	151	22	market	market	ADJ
globalce-210	151	23	safety	safety	NOUN
globalce-210	151	24	surveillance	surveillance	NOUN
globalce-210	151	25	,	,	PUNCT
globalce-210	151	26	bringing	bring	VERB
globalce-210	151	27	the	the	DET
globalce-210	151	28	process	process	NOUN
globalce-210	151	29	to	to	PART
globalce-210	151	30	detect	detect	VERB
globalce-210	151	31	potential	potential	ADJ
globalce-210	151	32	safety	safety	NOUN
globalce-210	151	33	signals	signal	NOUN
globalce-210	151	34	by	by	ADP
globalce-210	151	35	significantly	significantly	ADV
globalce-210	151	36	reducing	reduce	VERB
globalce-210	151	37	time	time	NOUN
globalce-210	151	38	with	with	ADP
globalce-210	151	39	ai	ai	NOUN
globalce-210	151	40	.	.	PUNCT
globalce-210	152	1	this	this	PRON
globalce-210	152	2	is	be	AUX
globalce-210	152	3	the	the	DET
globalce-210	152	4	use	use	NOUN
globalce-210	152	5	of	of	ADP
globalce-210	152	6	ai	ai	NOUN
globalce-210	152	7	in	in	ADP
globalce-210	152	8	implementing	implement	VERB
globalce-210	152	9	adaptive	adaptive	ADJ
globalce-210	152	10	pathways	pathway	NOUN
globalce-210	152	11	by	by	ADP
globalce-210	152	12	ema	ema	PROPN
globalce-210	152	13	,	,	PUNCT
globalce-210	152	14	leading	lead	VERB
globalce-210	152	15	to	to	ADP
globalce-210	152	16	quicker	quick	ADJ
globalce-210	152	17	entry	entry	NOUN
globalce-210	152	18	for	for	ADP
globalce-210	152	19	innovative	innovative	ADJ
globalce-210	152	20	medicines	medicine	NOUN
globalce-210	152	21	into	into	ADP
globalce-210	152	22	the	the	DET
globalce-210	152	23	hands	hand	NOUN
globalce-210	152	24	(	(	PUNCT
globalce-210	152	25	health	health	NOUN
globalce-210	152	26	)	)	PUNCT
globalce-210	152	27	of	of	ADP
globalce-210	152	28	patients	patient	NOUN
globalce-210	152	29	while	while	SCONJ
globalce-210	152	30	upholding	uphold	VERB
globalce-210	152	31	high	high	ADJ
globalce-210	152	32	safety	safety	NOUN
globalce-210	152	33	standards	standard	NOUN
globalce-210	152	34	.	.	PUNCT
globalce-210	153	1	for	for	ADP
globalce-210	153	2	instance	instance	NOUN
globalce-210	153	3	,	,	PUNCT
globalce-210	153	4	in	in	ADP
globalce-210	153	5	india	india	PROPN
globalce-210	153	6	,	,	PUNCT
globalce-210	153	7	ai	ai	ADJ
globalce-210	153	8	-	-	PUNCT
globalce-210	153	9	driven	drive	VERB
globalce-210	153	10	platforms	platform	NOUN
globalce-210	153	11	are	be	AUX
globalce-210	153	12	developed	develop	VERB
globalce-210	153	13	to	to	PART
globalce-210	153	14	automate	automate	VERB
globalce-210	153	15	the	the	DET
globalce-210	153	16	cdsco	cdsco	PROPN
globalce-210	153	17	regulatory	regulatory	ADJ
globalce-210	153	18	review	review	NOUN
globalce-210	153	19	process	process	NOUN
globalce-210	153	20	to	to	PART
globalce-210	153	21	save	save	VERB
globalce-210	153	22	substantial	substantial	ADJ
globalce-210	153	23	time	time	NOUN
globalce-210	153	24	and	and	CCONJ
globalce-210	153	25	effort	effort	NOUN
globalce-210	153	26	on	on	ADP
globalce-210	153	27	administrative	administrative	ADJ
globalce-210	153	28	tasks.49	tasks.49	PROPN
globalce-210	153	29	thus	thus	ADV
globalce-210	153	30	,	,	PUNCT
globalce-210	153	31	these	these	DET
globalce-210	153	32	customized	customize	VERB
globalce-210	153	33	ai	ai	PROPN
globalce-210	153	34	solutions	solution	NOUN
globalce-210	153	35	are	be	AUX
globalce-210	153	36	able	able	ADJ
globalce-210	153	37	to	to	PART
globalce-210	153	38	solve	solve	VERB
globalce-210	153	39	specific	specific	ADJ
globalce-210	153	40	regulatory	regulatory	ADJ
globalce-210	153	41	problems	problem	NOUN
globalce-210	153	42	and	and	CCONJ
globalce-210	153	43	also	also	ADV
globalce-210	153	44	lay	lie	VERB
globalce-210	153	45	the	the	DET
globalce-210	153	46	foundation	foundation	NOUN
globalce-210	153	47	gaur	gaur	NOUN
globalce-210	153	48	,	,	PUNCT
globalce-210	153	49	akram	akram	PROPN
globalce-210	153	50	,	,	PUNCT
globalce-210	153	51	singh	singh	PROPN
globalce-210	153	52	,	,	PUNCT
globalce-210	153	53	chauhan	chauhan	PROPN
globalce-210	153	54	:	:	PUNCT
globalce-210	153	55	artificial	artificial	ADJ
globalce-210	153	56	intelligence	intelligence	NOUN
globalce-210	153	57	-	-	PUNCT
globalce-210	153	58	driven	drive	VERB
globalce-210	153	59	insights	insight	NOUN
globalce-210	153	60	for	for	ADP
globalce-210	153	61	regulatory	regulatory	ADJ
globalce-210	153	62	intelligence	intelligence	NOUN
globalce-210	153	63	in	in	ADP
globalce-210	153	64	medical	medical	ADJ
globalce-210	153	65	devices	device	NOUN
globalce-210	153	66	:	:	PUNCT
globalce-210	153	67	evaluating	evaluate	VERB
globalce-210	153	68	ema	ema	PROPN
globalce-210	153	69	,	,	PUNCT
globalce-210	153	70	fda	fda	PROPN
globalce-210	153	71	,	,	PUNCT
globalce-210	153	72	and	and	CCONJ
globalce-210	153	73	cdsco	cdsco	PROPN
globalce-210	153	74	frameworks	framework	VERB
globalce-210	153	75	j	j	PROPN
globalce-210	153	76	global	global	ADJ
globalce-210	153	77	clinical	clinical	ADJ
globalce-210	153	78	engineering	engineering	NOUN
globalce-210	153	79	vol.7	vol.7	PROPN
globalce-210	153	80	issue	issue	NOUN
globalce-210	153	81	2	2	NUM
globalce-210	153	82	:	:	SYM
globalce-210	153	83	2025	2025	NUM
globalce-210	153	84	20	20	NUM
globalce-210	153	85	for	for	ADP
globalce-210	153	86	agility	agility	NOUN
globalce-210	153	87	in	in	ADP
globalce-210	153	88	regulation	regulation	NOUN
globalce-210	153	89	.	.	PUNCT
globalce-210	154	1	thus	thus	ADV
globalce-210	154	2	,	,	PUNCT
globalce-210	154	3	this	this	DET
globalce-210	154	4	review	review	NOUN
globalce-210	154	5	article	article	NOUN
globalce-210	154	6	exhibits	exhibit	VERB
globalce-210	154	7	these	these	DET
globalce-210	154	8	progressions	progression	NOUN
globalce-210	154	9	and	and	CCONJ
globalce-210	154	10	contextual	contextual	ADJ
globalce-210	154	11	analyses	analysis	NOUN
globalce-210	154	12	which	which	PRON
globalce-210	154	13	are	be	AUX
globalce-210	154	14	used	use	VERB
globalce-210	154	15	to	to	PART
globalce-210	154	16	understand	understand	VERB
globalce-210	154	17	the	the	DET
globalce-210	154	18	implementation	implementation	NOUN
globalce-210	154	19	of	of	ADP
globalce-210	154	20	ai	ai	NOUN
globalce-210	154	21	by	by	ADP
globalce-210	154	22	regulatory	regulatory	ADJ
globalce-210	154	23	bodies	body	NOUN
globalce-210	154	24	that	that	PRON
globalce-210	154	25	augment	augment	VERB
globalce-210	154	26	their	their	PRON
globalce-210	154	27	processes	process	NOUN
globalce-210	154	28	based	base	VERB
globalce-210	154	29	on	on	ADP
globalce-210	154	30	efficiency	efficiency	NOUN
globalce-210	154	31	criteria	criterion	NOUN
globalce-210	154	32	for	for	ADP
globalce-210	154	33	patient	patient	ADJ
globalce-210	154	34	safety	safety	NOUN
globalce-210	154	35	.	.	PUNCT
globalce-210	155	1	this	this	DET
globalce-210	155	2	observation	observation	NOUN
globalce-210	155	3	illustrates	illustrate	VERB
globalce-210	155	4	just	just	ADV
globalce-210	155	5	how	how	SCONJ
globalce-210	155	6	disruptive	disruptive	ADJ
globalce-210	155	7	ai	ai	NOUN
globalce-210	155	8	could	could	AUX
globalce-210	155	9	be	be	AUX
globalce-210	155	10	in	in	ADP
globalce-210	155	11	regulatory	regulatory	ADJ
globalce-210	155	12	intelligence	intelligence	NOUN
globalce-210	155	13	,	,	PUNCT
globalce-210	155	14	and	and	CCONJ
globalce-210	155	15	why	why	SCONJ
globalce-210	155	16	constant	constant	ADJ
globalce-210	155	17	innovation	innovation	NOUN
globalce-210	155	18	is	be	AUX
globalce-210	155	19	essential	essential	ADJ
globalce-210	155	20	to	to	PART
globalce-210	155	21	adapt	adapt	VERB
globalce-210	155	22	its	its	PRON
globalce-210	155	23	capabilities	capability	NOUN
globalce-210	155	24	to	to	ADP
globalce-210	155	25	the	the	DET
globalce-210	155	26	evolving	evolve	VERB
globalce-210	155	27	demands	demand	NOUN
globalce-210	155	28	of	of	ADP
globalce-210	155	29	their	their	PRON
globalce-210	155	30	regulations.49	regulations.49	NOUN
globalce-210	155	31	the	the	DET
globalce-210	155	32	fda	fda	PROPN
globalce-210	155	33	’s	’s	PART
globalce-210	155	34	pre	pre	ADJ
globalce-210	155	35	-	-	ADJ
globalce-210	155	36	cert	cert	ADJ
globalce-210	155	37	program	program	NOUN
globalce-210	155	38	is	be	AUX
globalce-210	155	39	designed	design	VERB
globalce-210	155	40	to	to	PART
globalce-210	155	41	enhance	enhance	VERB
globalce-210	155	42	regulatory	regulatory	ADJ
globalce-210	155	43	efficiency	efficiency	NOUN
globalce-210	155	44	and	and	CCONJ
globalce-210	155	45	innovation	innovation	NOUN
globalce-210	155	46	.	.	PUNCT
globalce-210	156	1	pre	pre	ADJ
globalce-210	156	2	-	-	ADJ
globalce-210	156	3	certified	certified	ADJ
globalce-210	156	4	companies	company	NOUN
globalce-210	156	5	can	can	AUX
globalce-210	156	6	release	release	VERB
globalce-210	156	7	updates	update	NOUN
globalce-210	156	8	and	and	CCONJ
globalce-210	156	9	new	new	ADJ
globalce-210	156	10	products	product	NOUN
globalce-210	156	11	more	more	ADV
globalce-210	156	12	quickly	quickly	ADV
globalce-210	156	13	,	,	PUNCT
globalce-210	156	14	allowing	allow	VERB
globalce-210	156	15	for	for	ADP
globalce-210	156	16	faster	fast	ADJ
globalce-210	156	17	adoption	adoption	NOUN
globalce-210	156	18	of	of	ADP
globalce-210	156	19	innovative	innovative	ADJ
globalce-210	156	20	technologies	technology	NOUN
globalce-210	156	21	.	.	PUNCT
globalce-210	157	1	this	this	DET
globalce-210	157	2	program	program	NOUN
globalce-210	157	3	also	also	ADV
globalce-210	157	4	provides	provide	VERB
globalce-210	157	5	flexibility	flexibility	NOUN
globalce-210	157	6	in	in	ADP
globalce-210	157	7	evolving	evolve	VERB
globalce-210	157	8	with	with	ADP
globalce-210	157	9	technology	technology	NOUN
globalce-210	157	10	,	,	PUNCT
globalce-210	157	11	particularly	particularly	ADV
globalce-210	157	12	for	for	ADP
globalce-210	157	13	ai	ai	NOUN
globalce-210	157	14	/	/	SYM
globalce-210	157	15	ml	ml	NOUN
globalce-210	157	16	,	,	PUNCT
globalce-210	157	17	while	while	SCONJ
globalce-210	157	18	maintaining	maintain	VERB
globalce-210	157	19	a	a	DET
globalce-210	157	20	focus	focus	NOUN
globalce-210	157	21	on	on	ADP
globalce-210	157	22	safety	safety	NOUN
globalce-210	157	23	through	through	ADP
globalce-210	157	24	post	post	ADJ
globalce-210	157	25	-	-	ADJ
globalce-210	157	26	market	market	ADJ
globalce-210	157	27	monitoring	monitoring	NOUN
globalce-210	157	28	and	and	CCONJ
globalce-210	157	29	company	company	NOUN
globalce-210	157	30	excellence	excellence	NOUN
globalce-210	157	31	reviews.49	reviews.49	PROPN
globalce-210	157	32	ethical	ethical	ADJ
globalce-210	157	33	and	and	CCONJ
globalce-210	157	34	transparent	transparent	ADJ
globalce-210	157	35	ai	ai	ADJ
globalce-210	157	36	progress	progress	NOUN
globalce-210	157	37	in	in	ADP
globalce-210	157	38	the	the	DET
globalce-210	157	39	evolution	evolution	NOUN
globalce-210	157	40	of	of	ADP
globalce-210	157	41	responsible	responsible	ADJ
globalce-210	157	42	ai	ai	NOUN
globalce-210	157	43	frameworks	framework	NOUN
globalce-210	157	44	has	have	AUX
globalce-210	157	45	become	become	VERB
globalce-210	157	46	more	more	ADV
globalce-210	157	47	urgent	urgent	ADJ
globalce-210	157	48	because	because	SCONJ
globalce-210	157	49	medical	medical	ADJ
globalce-210	157	50	devices	device	NOUN
globalce-210	157	51	are	be	AUX
globalce-210	157	52	the	the	DET
globalce-210	157	53	area	area	NOUN
globalce-210	157	54	where	where	SCONJ
globalce-210	157	55	advanced	advanced	ADJ
globalce-210	157	56	regulatory	regulatory	ADJ
globalce-210	157	57	decisions	decision	NOUN
globalce-210	157	58	are	be	AUX
globalce-210	157	59	made	make	VERB
globalce-210	157	60	,	,	PUNCT
globalce-210	157	61	at	at	ADP
globalce-210	157	62	least	least	ADJ
globalce-210	157	63	partially	partially	ADV
globalce-210	157	64	by	by	ADP
globalce-210	157	65	an	an	DET
globalce-210	157	66	ai	ai	NOUN
globalce-210	157	67	system	system	NOUN
globalce-210	157	68	.	.	PUNCT
globalce-210	158	1	this	this	PRON
globalce-210	158	2	is	be	AUX
globalce-210	158	3	an	an	DET
globalce-210	158	4	additional	additional	ADJ
globalce-210	158	5	measure	measure	NOUN
globalce-210	158	6	important	important	ADJ
globalce-210	158	7	to	to	PART
globalce-210	158	8	ensure	ensure	VERB
globalce-210	158	9	transparency	transparency	NOUN
globalce-210	158	10	and	and	CCONJ
globalce-210	158	11	accountability	accountability	NOUN
globalce-210	158	12	,	,	PUNCT
globalce-210	158	13	in	in	ADP
globalce-210	158	14	turn	turn	NOUN
globalce-210	158	15	ensuring	ensure	VERB
globalce-210	158	16	the	the	DET
globalce-210	158	17	trustworthiness	trustworthiness	NOUN
globalce-210	158	18	of	of	ADP
globalce-210	158	19	ai	ai	NOUN
globalce-210	158	20	-	-	PUNCT
globalce-210	158	21	driven	drive	VERB
globalce-210	158	22	processes	process	NOUN
globalce-210	158	23	for	for	ADP
globalce-210	158	24	public	public	ADJ
globalce-210	158	25	health	health	NOUN
globalce-210	158	26	maintenance	maintenance	NOUN
globalce-210	158	27	.	.	PUNCT
globalce-210	159	1	ethical	ethical	ADJ
globalce-210	159	2	ai	ai	NOUN
globalce-210	159	3	frameworks	framework	NOUN
globalce-210	159	4	are	be	AUX
globalce-210	159	5	created	create	VERB
globalce-210	159	6	to	to	PART
globalce-210	159	7	enable	enable	VERB
globalce-210	159	8	the	the	DET
globalce-210	159	9	development	development	NOUN
globalce-210	159	10	of	of	ADP
globalce-210	159	11	these	these	DET
globalce-210	159	12	systems	system	NOUN
globalce-210	159	13	,	,	PUNCT
globalce-210	159	14	so	so	SCONJ
globalce-210	159	15	that	that	SCONJ
globalce-210	159	16	they	they	PRON
globalce-210	159	17	are	be	AUX
globalce-210	159	18	designed	design	VERB
globalce-210	159	19	and	and	CCONJ
globalce-210	159	20	implemented	implement	VERB
globalce-210	159	21	in	in	ADP
globalce-210	159	22	line	line	NOUN
globalce-210	159	23	with	with	ADP
globalce-210	159	24	ethical	ethical	ADJ
globalce-210	159	25	principles	principle	NOUN
globalce-210	159	26	as	as	ADV
globalce-210	159	27	well	well	ADV
globalce-210	159	28	as	as	ADP
globalce-210	159	29	regulatory	regulatory	ADJ
globalce-210	159	30	standards.49	standards.49	NOUN
globalce-210	159	31	this	this	PRON
globalce-210	159	32	consists	consist	VERB
globalce-210	159	33	of	of	ADP
globalce-210	159	34	having	have	VERB
globalce-210	159	35	protocols	protocol	NOUN
globalce-210	159	36	for	for	ADP
globalce-210	159	37	data	datum	NOUN
globalce-210	159	38	privacy	privacy	NOUN
globalce-210	159	39	,	,	PUNCT
globalce-210	159	40	bias	bias	NOUN
globalce-210	159	41	mitigation	mitigation	NOUN
globalce-210	159	42	,	,	PUNCT
globalce-210	159	43	and	and	CCONJ
globalce-210	159	44	ensuring	ensure	VERB
globalce-210	159	45	equitable	equitable	ADJ
globalce-210	159	46	access	access	NOUN
globalce-210	159	47	to	to	ADP
globalce-210	159	48	all	all	ADV
globalce-210	159	49	-	-	PUNCT
globalce-210	159	50	driven	drive	VERB
globalce-210	159	51	insights	insight	NOUN
globalce-210	159	52	.	.	PUNCT
globalce-210	160	1	these	these	DET
globalce-210	160	2	frameworks	framework	NOUN
globalce-210	160	3	also	also	ADV
globalce-210	160	4	underscore	underscore	VERB
globalce-210	160	5	the	the	DET
globalce-210	160	6	need	need	NOUN
globalce-210	160	7	for	for	ADP
globalce-210	160	8	accountability	accountability	NOUN
globalce-210	160	9	—	—	PUNCT
globalce-210	160	10	that	that	SCONJ
globalce-210	160	11	people	people	NOUN
globalce-210	160	12	must	must	AUX
globalce-210	160	13	know	know	VERB
globalce-210	160	14	who	who	PRON
globalce-210	160	15	is	be	AUX
globalce-210	160	16	responsible	responsible	ADJ
globalce-210	160	17	in	in	ADP
globalce-210	160	18	cases	case	NOUN
globalce-210	160	19	where	where	SCONJ
globalce-210	160	20	ai	ai	VERB
globalce-210	160	21	systems	system	NOUN
globalce-210	160	22	produce	produce	VERB
globalce-210	160	23	harm	harm	NOUN
globalce-210	160	24	.	.	PUNCT
globalce-210	161	1	the	the	DET
globalce-210	161	2	use	use	NOUN
globalce-210	161	3	of	of	ADP
globalce-210	161	4	explainable	explainable	ADJ
globalce-210	161	5	ai	ai	NOUN
globalce-210	161	6	(	(	PUNCT
globalce-210	161	7	xai	xai	PROPN
globalce-210	161	8	)	)	PUNCT
globalce-210	161	9	models	model	NOUN
globalce-210	161	10	provides	provide	VERB
globalce-210	161	11	one	one	NUM
globalce-210	161	12	of	of	ADP
globalce-210	161	13	the	the	DET
globalce-210	161	14	most	most	ADV
globalce-210	161	15	important	important	ADJ
globalce-210	161	16	advancements	advancement	NOUN
globalce-210	161	17	in	in	ADP
globalce-210	161	18	this	this	DET
globalce-210	161	19	space	space	NOUN
globalce-210	161	20	.	.	PUNCT
globalce-210	162	1	in	in	ADP
globalce-210	162	2	cases	case	NOUN
globalce-210	162	3	where	where	SCONJ
globalce-210	162	4	traditional	traditional	ADJ
globalce-210	162	5	ai	ai	NOUN
globalce-210	162	6	systems	system	NOUN
globalce-210	162	7	are	be	AUX
globalce-210	162	8	essentially	essentially	ADV
globalce-210	162	9	“	"	PUNCT
globalce-210	162	10	black	black	ADJ
globalce-210	162	11	boxes	box	NOUN
globalce-210	162	12	,	,	PUNCT
globalce-210	162	13	”	"	PUNCT
globalce-210	162	14	withholding	withhold	VERB
globalce-210	162	15	any	any	DET
globalce-210	162	16	information	information	NOUN
globalce-210	162	17	about	about	ADP
globalce-210	162	18	their	their	PRON
globalce-210	162	19	decision	decision	NOUN
globalce-210	162	20	-	-	PUNCT
globalce-210	162	21	making	make	VERB
globalce-210	162	22	process	process	NOUN
globalce-210	162	23	,	,	PUNCT
globalce-210	162	24	xai	xai	PROPN
globalce-210	162	25	models	model	NOUN
globalce-210	162	26	aim	aim	VERB
globalce-210	162	27	to	to	PART
globalce-210	162	28	better	well	ADV
globalce-210	162	29	unpack	unpack	VERB
globalce-210	162	30	the	the	DET
globalce-210	162	31	results	result	NOUN
globalce-210	162	32	of	of	ADP
globalce-210	162	33	our	our	PRON
globalce-210	162	34	ai	ai	NOUN
globalce-210	162	35	systems	system	NOUN
globalce-210	162	36	.	.	PUNCT
globalce-210	163	1	regulators	regulator	NOUN
globalce-210	163	2	and	and	CCONJ
globalce-210	163	3	stakeholders	stakeholder	NOUN
globalce-210	163	4	should	should	AUX
globalce-210	163	5	be	be	AUX
globalce-210	163	6	able	able	ADJ
globalce-210	163	7	to	to	PART
globalce-210	163	8	unpack	unpack	VERB
globalce-210	163	9	the	the	DET
globalce-210	163	10	decision	decision	NOUN
globalce-210	163	11	criteria	criterion	NOUN
globalce-210	163	12	upon	upon	SCONJ
globalce-210	163	13	which	which	PRON
globalce-210	163	14	the	the	DET
globalce-210	163	15	ai	ai	NOUN
globalce-210	163	16	has	have	AUX
globalce-210	163	17	based	base	VERB
globalce-210	163	18	its	its	PRON
globalce-210	163	19	conclusions	conclusion	NOUN
globalce-210	163	20	,	,	PUNCT
globalce-210	163	21	so	so	SCONJ
globalce-210	163	22	that	that	SCONJ
globalce-210	163	23	decisions	decision	NOUN
globalce-210	163	24	at	at	ADP
globalce-210	163	25	any	any	DET
globalce-210	163	26	time	time	NOUN
globalce-210	163	27	can	can	AUX
globalce-210	163	28	still	still	ADV
globalce-210	163	29	accompany	accompany	VERB
globalce-210	163	30	handling	handle	VERB
globalce-210	163	31	scrutiny	scrutiny	NOUN
globalce-210	163	32	.	.	PUNCT
globalce-210	164	1	for	for	ADP
globalce-210	164	2	example	example	NOUN
globalce-210	164	3	,	,	PUNCT
globalce-210	164	4	subjecting	subject	VERB
globalce-210	164	5	an	an	DET
globalce-210	164	6	xai	xai	PROPN
globalce-210	164	7	model	model	NOUN
globalce-210	164	8	to	to	ADP
globalce-210	164	9	a	a	DET
globalce-210	164	10	regulatory	regulatory	ADJ
globalce-210	164	11	body	body	NOUN
globalce-210	164	12	looking	look	VERB
globalce-210	164	13	at	at	ADP
globalce-210	164	14	the	the	DET
globalce-210	164	15	integrity	integrity	NOUN
globalce-210	164	16	of	of	ADP
globalce-210	164	17	any	any	DET
globalce-210	164	18	selected	select	VERB
globalce-210	164	19	medical	medical	ADJ
globalce-210	164	20	device	device	NOUN
globalce-210	164	21	should	should	AUX
globalce-210	164	22	be	be	AUX
globalce-210	164	23	able	able	ADJ
globalce-210	164	24	to	to	PART
globalce-210	164	25	understand	understand	VERB
globalce-210	164	26	how	how	SCONJ
globalce-210	164	27	exactly	exactly	ADV
globalce-210	164	28	it	it	PRON
globalce-210	164	29	arrived	arrive	VERB
globalce-210	164	30	at	at	ADP
globalce-210	164	31	its	its	PRON
globalce-210	164	32	decision	decision	NOUN
globalce-210	164	33	based	base	VERB
globalce-210	164	34	on	on	ADP
globalce-210	164	35	concrete	concrete	ADJ
globalce-210	164	36	data	datum	NOUN
globalce-210	164	37	and	and	CCONJ
globalce-210	164	38	patterns	pattern	NOUN
globalce-210	164	39	.	.	PUNCT
globalce-210	165	1	the	the	DET
globalce-210	165	2	fda	fda	PROPN
globalce-210	165	3	is	be	AUX
globalce-210	165	4	also	also	ADV
globalce-210	165	5	showing	show	VERB
globalce-210	165	6	initiatives	initiative	NOUN
globalce-210	165	7	in	in	ADP
globalce-210	165	8	improving	improve	VERB
globalce-210	165	9	more	more	ADV
globalce-210	165	10	ethically	ethically	ADV
globalce-210	165	11	aligned	aligned	ADJ
globalce-210	165	12	and	and	CCONJ
globalce-210	165	13	transparent	transparent	ADJ
globalce-210	165	14	ai	ai	VERB
globalce-210	165	15	through	through	ADP
globalce-210	165	16	projects	project	NOUN
globalce-210	165	17	such	such	ADJ
globalce-210	165	18	as	as	ADP
globalce-210	165	19	those	those	PRON
globalce-210	165	20	exploring	explore	VERB
globalce-210	165	21	ways	way	NOUN
globalce-210	165	22	to	to	PART
globalce-210	165	23	bring	bring	VERB
globalce-210	165	24	xai	xai	PROPN
globalce-210	165	25	into	into	ADP
globalce-210	165	26	its	its	PRON
globalce-210	165	27	regulatory	regulatory	ADJ
globalce-210	165	28	review	review	NOUN
globalce-210	165	29	pathways	pathway	NOUN
globalce-210	165	30	.	.	PUNCT
globalce-210	166	1	by	by	ADP
globalce-210	166	2	requiring	require	VERB
globalce-210	166	3	that	that	SCONJ
globalce-210	166	4	ai	ai	NOUN
globalce-210	166	5	models	model	NOUN
globalce-210	166	6	used	use	VERB
globalce-210	166	7	in	in	ADP
globalce-210	166	8	regulatory	regulatory	ADJ
globalce-210	166	9	submissions	submission	NOUN
globalce-210	166	10	be	be	VERB
globalce-210	166	11	interpretable	interpretable	ADJ
globalce-210	166	12	,	,	PUNCT
globalce-210	166	13	the	the	DET
globalce-210	166	14	fda	fda	PROPN
globalce-210	166	15	is	be	AUX
globalce-210	166	16	ensuring	ensure	VERB
globalce-210	166	17	that	that	SCONJ
globalce-210	166	18	those	those	DET
globalce-210	166	19	tools	tool	NOUN
globalce-210	166	20	can	can	AUX
globalce-210	166	21	have	have	VERB
globalce-210	166	22	both	both	PRON
globalce-210	166	23	regulator	regulator	NOUN
globalce-210	166	24	and	and	CCONJ
globalce-210	166	25	patient	patient	NOUN
globalce-210	166	26	trust	trust	NOUN
globalce-210	166	27	.	.	PUNCT
globalce-210	167	1	on	on	ADP
globalce-210	167	2	the	the	DET
globalce-210	167	3	other	other	ADJ
globalce-210	167	4	hand	hand	NOUN
globalce-210	167	5	,	,	PUNCT
globalce-210	167	6	some	some	DET
globalce-210	167	7	form	form	NOUN
globalce-210	167	8	of	of	ADP
globalce-210	167	9	guidance	guidance	NOUN
globalce-210	167	10	and	and	CCONJ
globalce-210	167	11	transparency	transparency	NOUN
globalce-210	167	12	in	in	ADP
globalce-210	167	13	strategy	strategy	NOUN
globalce-210	167	14	,	,	PUNCT
globalce-210	167	15	be	be	AUX
globalce-210	167	16	it	it	PRON
globalce-210	167	17	through	through	ADP
globalce-210	167	18	routine	routine	ADJ
globalce-210	167	19	audit	audit	NOUN
globalce-210	167	20	processes	process	NOUN
globalce-210	167	21	for	for	ADP
globalce-210	167	22	addition	addition	NOUN
globalce-210	167	23	or	or	CCONJ
globalce-210	167	24	on	on	ADP
globalce-210	167	25	-	-	PUNCT
globalce-210	167	26	account	account	NOUN
globalce-210	167	27	validation	validation	NOUN
globalce-210	167	28	built	build	VERB
globalce-210	167	29	-	-	PUNCT
globalce-210	167	30	in	in	ADP
globalce-210	167	31	algorithms	algorithm	NOUN
globalce-210	167	32	,	,	PUNCT
globalce-210	167	33	at	at	ADP
globalce-210	167	34	ema	ema	PROPN
globalce-210	167	35	and	and	CCONJ
globalce-210	167	36	cdsco	cdsco	PROPN
globalce-210	167	37	are	be	AUX
globalce-210	167	38	likely	likely	ADJ
globalce-210	167	39	to	to	PART
globalce-210	167	40	hold	hold	VERB
globalce-210	168	1	position.49	position.49	PROPN
globalce-210	168	2	the	the	DET
globalce-210	168	3	fda	fda	PROPN
globalce-210	168	4	is	be	AUX
globalce-210	168	5	also	also	ADV
globalce-210	168	6	showing	show	VERB
globalce-210	168	7	initiatives	initiative	NOUN
globalce-210	168	8	in	in	ADP
globalce-210	168	9	improving	improve	VERB
globalce-210	168	10	more	more	ADV
globalce-210	168	11	ethically	ethically	ADV
globalce-210	168	12	aligned	aligned	ADJ
globalce-210	168	13	and	and	CCONJ
globalce-210	168	14	transparent	transparent	ADJ
globalce-210	168	15	ai	ai	VERB
globalce-210	168	16	through	through	ADP
globalce-210	168	17	projects	project	NOUN
globalce-210	168	18	such	such	ADJ
globalce-210	168	19	as	as	ADP
globalce-210	168	20	those	those	PRON
globalce-210	168	21	exploring	explore	VERB
globalce-210	168	22	ways	way	NOUN
globalce-210	168	23	to	to	PART
globalce-210	168	24	bring	bring	VERB
globalce-210	168	25	xai	xai	PROPN
globalce-210	168	26	into	into	ADP
globalce-210	168	27	its	its	PRON
globalce-210	168	28	regulatory	regulatory	ADJ
globalce-210	168	29	review	review	NOUN
globalce-210	168	30	pathways	pathway	NOUN
globalce-210	168	31	.	.	PUNCT
globalce-210	169	1	by	by	ADP
globalce-210	169	2	requiring	require	VERB
globalce-210	169	3	that	that	SCONJ
globalce-210	169	4	ai	ai	NOUN
globalce-210	169	5	models	model	NOUN
globalce-210	169	6	used	use	VERB
globalce-210	169	7	in	in	ADP
globalce-210	169	8	regulatory	regulatory	ADJ
globalce-210	169	9	submissions	submission	NOUN
globalce-210	169	10	be	be	VERB
globalce-210	169	11	interpretable	interpretable	ADJ
globalce-210	169	12	,	,	PUNCT
globalce-210	169	13	the	the	DET
globalce-210	169	14	fda	fda	PROPN
globalce-210	169	15	is	be	AUX
globalce-210	169	16	ensuring	ensure	VERB
globalce-210	169	17	that	that	SCONJ
globalce-210	169	18	those	those	DET
globalce-210	169	19	tools	tool	NOUN
globalce-210	169	20	can	can	AUX
globalce-210	169	21	have	have	VERB
globalce-210	169	22	both	both	PRON
globalce-210	169	23	regulator	regulator	NOUN
globalce-210	169	24	and	and	CCONJ
globalce-210	169	25	patient	patient	NOUN
globalce-210	169	26	trust	trust	NOUN
globalce-210	169	27	.	.	PUNCT
globalce-210	170	1	on	on	ADP
globalce-210	170	2	the	the	DET
globalce-210	170	3	other	other	ADJ
globalce-210	170	4	hand	hand	NOUN
globalce-210	170	5	,	,	PUNCT
globalce-210	170	6	some	some	DET
globalce-210	170	7	form	form	NOUN
globalce-210	170	8	of	of	ADP
globalce-210	170	9	guidance	guidance	NOUN
globalce-210	170	10	and	and	CCONJ
globalce-210	170	11	transparency	transparency	NOUN
globalce-210	170	12	in	in	ADP
globalce-210	170	13	strategy	strategy	NOUN
globalce-210	170	14	,	,	PUNCT
globalce-210	170	15	be	be	AUX
globalce-210	170	16	it	it	PRON
globalce-210	170	17	through	through	ADP
globalce-210	170	18	routine	routine	ADJ
globalce-210	170	19	audit	audit	NOUN
globalce-210	170	20	processes	process	NOUN
globalce-210	170	21	for	for	ADP
globalce-210	170	22	addition	addition	NOUN
globalce-210	170	23	or	or	CCONJ
globalce-210	170	24	on	on	ADP
globalce-210	170	25	-	-	PUNCT
globalce-210	170	26	account	account	NOUN
globalce-210	170	27	validation	validation	NOUN
globalce-210	170	28	built	build	VERB
globalce-210	170	29	-	-	PUNCT
globalce-210	170	30	in	in	ADP
globalce-210	170	31	algorithms	algorithm	NOUN
globalce-210	170	32	,	,	PUNCT
globalce-210	170	33	at	at	ADP
globalce-210	170	34	ema	ema	PROPN
globalce-210	170	35	and	and	CCONJ
globalce-210	170	36	cdsco	cdsco	PROPN
globalce-210	170	37	are	be	AUX
globalce-210	170	38	likely	likely	ADJ
globalce-210	170	39	to	to	PART
globalce-210	170	40	hold	hold	VERB
globalce-210	170	41	position.49	position.49	PROPN
globalce-210	170	42	one	one	NUM
globalce-210	170	43	world	world	NOUN
globalce-210	170	44	,	,	PUNCT
globalce-210	170	45	one	one	NUM
globalce-210	170	46	regulation	regulation	NOUN
globalce-210	170	47	in	in	ADP
globalce-210	170	48	an	an	DET
globalce-210	170	49	era	era	NOUN
globalce-210	170	50	where	where	SCONJ
globalce-210	170	51	ai	ai	VERB
globalce-210	170	52	technologies	technology	NOUN
globalce-210	170	53	are	be	AUX
globalce-210	170	54	rapidly	rapidly	ADV
globalce-210	170	55	advancing	advance	VERB
globalce-210	170	56	and	and	CCONJ
globalce-210	170	57	transforming	transform	VERB
globalce-210	170	58	the	the	DET
globalce-210	170	59	landscape	landscape	NOUN
globalce-210	170	60	of	of	ADP
globalce-210	170	61	medical	medical	ADJ
globalce-210	170	62	devices	device	NOUN
globalce-210	170	63	,	,	PUNCT
globalce-210	170	64	the	the	DET
globalce-210	170	65	need	need	NOUN
globalce-210	170	66	for	for	ADP
globalce-210	170	67	a	a	DET
globalce-210	170	68	harmonized	harmonized	ADJ
globalce-210	170	69	global	global	ADJ
globalce-210	170	70	regulatory	regulatory	ADJ
globalce-210	170	71	framework	framework	NOUN
globalce-210	170	72	has	have	AUX
globalce-210	170	73	become	become	VERB
globalce-210	170	74	increasingly	increasingly	ADV
globalce-210	170	75	evident	evident	ADJ
globalce-210	170	76	.	.	PUNCT
globalce-210	171	1	the	the	DET
globalce-210	171	2	vision	vision	NOUN
globalce-210	171	3	of	of	ADP
globalce-210	171	4	“	"	PUNCT
globalce-210	171	5	one	one	NUM
globalce-210	171	6	world	world	NOUN
globalce-210	171	7	,	,	PUNCT
globalce-210	171	8	one	one	NUM
globalce-210	171	9	regulation	regulation	NOUN
globalce-210	171	10	”	"	PUNCT
globalce-210	171	11	encapsulates	encapsulate	VERB
globalce-210	171	12	the	the	DET
globalce-210	171	13	aspiration	aspiration	NOUN
globalce-210	171	14	for	for	ADP
globalce-210	171	15	a	a	DET
globalce-210	171	16	unified	unified	ADJ
globalce-210	171	17	approach	approach	NOUN
globalce-210	171	18	to	to	PART
globalce-210	171	19	ensure	ensure	VERB
globalce-210	171	20	that	that	SCONJ
globalce-210	171	21	ai	ai	VERB
globalce-210	171	22	-	-	PUNCT
globalce-210	171	23	powered	power	VERB
globalce-210	171	24	medical	medical	ADJ
globalce-210	171	25	devices	device	NOUN
globalce-210	171	26	meet	meet	VERB
globalce-210	171	27	consistent	consistent	ADJ
globalce-210	171	28	standards	standard	NOUN
globalce-210	171	29	of	of	ADP
globalce-210	171	30	safety	safety	NOUN
globalce-210	171	31	,	,	PUNCT
globalce-210	171	32	effectiveness	effectiveness	NOUN
globalce-210	171	33	,	,	PUNCT
globalce-210	171	34	and	and	CCONJ
globalce-210	171	35	ethical	ethical	ADJ
globalce-210	171	36	use	use	NOUN
globalce-210	171	37	across	across	ADP
globalce-210	171	38	all	all	DET
globalce-210	171	39	regions	region	NOUN
globalce-210	171	40	.	.	PUNCT
globalce-210	172	1	this	this	DET
globalce-210	172	2	vision	vision	NOUN
globalce-210	172	3	is	be	AUX
globalce-210	172	4	not	not	PART
globalce-210	172	5	just	just	ADV
globalce-210	172	6	about	about	ADP
globalce-210	172	7	standardization	standardization	NOUN
globalce-210	172	8	but	but	CCONJ
globalce-210	172	9	about	about	ADP
globalce-210	172	10	fostering	foster	VERB
globalce-210	172	11	an	an	DET
globalce-210	172	12	environment	environment	NOUN
globalce-210	172	13	where	where	SCONJ
globalce-210	172	14	innovation	innovation	NOUN
globalce-210	172	15	can	can	AUX
globalce-210	172	16	thrive	thrive	VERB
globalce-210	172	17	without	without	ADP
globalce-210	172	18	being	be	AUX
globalce-210	172	19	hindered	hinder	VERB
globalce-210	172	20	by	by	ADP
globalce-210	172	21	disparate	disparate	ADJ
globalce-210	172	22	regulatory	regulatory	ADJ
globalce-210	172	23	requirements	requirement	NOUN
globalce-210	172	24	.	.	PUNCT
globalce-210	173	1	by	by	ADP
globalce-210	173	2	aligning	align	VERB
globalce-210	173	3	regulatory	regulatory	ADJ
globalce-210	173	4	approaches	approach	NOUN
globalce-210	173	5	,	,	PUNCT
globalce-210	173	6	we	we	PRON
globalce-210	173	7	can	can	AUX
globalce-210	173	8	facilitate	facilitate	VERB
globalce-210	173	9	the	the	DET
globalce-210	173	10	rapid	rapid	ADJ
globalce-210	173	11	deployment	deployment	NOUN
globalce-210	173	12	of	of	ADP
globalce-210	173	13	ai	ai	PROPN
globalce-210	173	14	technologies	technology	NOUN
globalce-210	173	15	,	,	PUNCT
globalce-210	173	16	making	make	VERB
globalce-210	173	17	advanced	advanced	ADJ
globalce-210	173	18	healthcare	healthcare	NOUN
globalce-210	173	19	solutions	solution	NOUN
globalce-210	173	20	more	more	ADV
globalce-210	173	21	accessible	accessible	ADJ
globalce-210	173	22	globally	globally	ADV
globalce-210	173	23	.	.	PUNCT
globalce-210	174	1	moreover	moreover	ADV
globalce-210	174	2	,	,	PUNCT
globalce-210	174	3	a	a	DET
globalce-210	174	4	unified	unified	ADJ
globalce-210	174	5	framework	framework	NOUN
globalce-210	174	6	builds	build	VERB
globalce-210	174	7	trust	trust	NOUN
globalce-210	174	8	in	in	ADP
globalce-210	174	9	these	these	DET
globalce-210	174	10	technologies	technology	NOUN
globalce-210	174	11	by	by	ADP
globalce-210	174	12	ensuring	ensure	VERB
globalce-210	174	13	rigorous	rigorous	ADJ
globalce-210	174	14	oversight	oversight	NOUN
globalce-210	174	15	and	and	CCONJ
globalce-210	174	16	consistent	consistent	ADJ
globalce-210	174	17	performance	performance	NOUN
globalce-210	174	18	standards	standard	NOUN
globalce-210	174	19	.	.	PUNCT
globalce-210	175	1	it	it	PRON
globalce-210	175	2	also	also	ADV
globalce-210	175	3	promotes	promote	VERB
globalce-210	175	4	collaboration	collaboration	NOUN
globalce-210	175	5	among	among	ADP
globalce-210	175	6	regulatory	regulatory	ADJ
globalce-210	175	7	bodies	body	NOUN
globalce-210	175	8	,	,	PUNCT
globalce-210	175	9	streamlining	streamline	VERB
globalce-210	175	10	the	the	DET
globalce-210	175	11	approval	approval	NOUN
globalce-210	175	12	process	process	NOUN
globalce-210	175	13	and	and	CCONJ
globalce-210	175	14	reducing	reduce	VERB
globalce-210	175	15	the	the	DET
globalce-210	175	16	burden	burden	NOUN
globalce-210	175	17	on	on	ADP
globalce-210	175	18	manufacturers	manufacturer	NOUN
globalce-210	175	19	.	.	PUNCT
globalce-210	176	1	ultimately	ultimately	ADV
globalce-210	176	2	,	,	PUNCT
globalce-210	176	3	the	the	DET
globalce-210	176	4	“	"	PUNCT
globalce-210	176	5	one	one	NUM
globalce-210	176	6	world	world	NOUN
globalce-210	176	7	,	,	PUNCT
globalce-210	176	8	one	one	NUM
globalce-210	176	9	regulation	regulation	NOUN
globalce-210	176	10	”	"	PUNCT
globalce-210	176	11	approach	approach	NOUN
globalce-210	176	12	is	be	AUX
globalce-210	176	13	essential	essential	ADJ
globalce-210	176	14	for	for	ADP
globalce-210	176	15	realizing	realize	VERB
globalce-210	176	16	the	the	DET
globalce-210	176	17	full	full	ADJ
globalce-210	176	18	potential	potential	ADJ
globalce-210	176	19	21	21	NUM
globalce-210	176	20	j	j	PROPN
globalce-210	176	21	global	global	ADJ
globalce-210	176	22	clinical	clinical	ADJ
globalce-210	176	23	engineering	engineering	NOUN
globalce-210	176	24	vol.7	vol.7	PROPN
globalce-210	176	25	issue	issue	NOUN
globalce-210	176	26	2	2	NUM
globalce-210	176	27	:	:	SYM
globalce-210	176	28	2025	2025	NUM
globalce-210	176	29	gaur	gaur	NOUN
globalce-210	176	30	,	,	PUNCT
globalce-210	176	31	akram	akram	PROPN
globalce-210	176	32	,	,	PUNCT
globalce-210	176	33	singh	singh	PROPN
globalce-210	176	34	,	,	PUNCT
globalce-210	176	35	chauhan	chauhan	PROPN
globalce-210	176	36	:	:	PUNCT
globalce-210	176	37	artificial	artificial	ADJ
globalce-210	176	38	intelligence	intelligence	NOUN
globalce-210	176	39	-	-	PUNCT
globalce-210	176	40	driven	drive	VERB
globalce-210	176	41	insights	insight	NOUN
globalce-210	176	42	for	for	ADP
globalce-210	176	43	regulatory	regulatory	ADJ
globalce-210	176	44	intelligence	intelligence	NOUN
globalce-210	176	45	in	in	ADP
globalce-210	176	46	medical	medical	ADJ
globalce-210	176	47	devices	device	NOUN
globalce-210	176	48	:	:	PUNCT
globalce-210	176	49	evaluating	evaluate	VERB
globalce-210	176	50	ema	ema	PROPN
globalce-210	176	51	,	,	PUNCT
globalce-210	176	52	fda	fda	PROPN
globalce-210	176	53	,	,	PUNCT
globalce-210	176	54	and	and	CCONJ
globalce-210	176	55	cdsco	cdsco	PROPN
globalce-210	176	56	frameworks	framework	NOUN
globalce-210	176	57	of	of	ADP
globalce-210	176	58	ai	ai	VERB
globalce-210	176	59	in	in	ADP
globalce-210	176	60	healthcare	healthcare	NOUN
globalce-210	176	61	,	,	PUNCT
globalce-210	176	62	ensuring	ensure	VERB
globalce-210	176	63	that	that	SCONJ
globalce-210	176	64	these	these	DET
globalce-210	176	65	technologies	technology	NOUN
globalce-210	176	66	can	can	AUX
globalce-210	176	67	be	be	AUX
globalce-210	176	68	safely	safely	ADV
globalce-210	176	69	and	and	CCONJ
globalce-210	176	70	effectively	effectively	ADV
globalce-210	176	71	utilized	utilize	VERB
globalce-210	176	72	to	to	PART
globalce-210	176	73	improve	improve	VERB
globalce-210	176	74	patient	patient	ADJ
globalce-210	176	75	outcomes	outcome	NOUN
globalce-210	176	76	globally.49	globally.49	AUX
globalce-210	176	77	conclusion	conclusion	NOUN
globalce-210	176	78	the	the	DET
globalce-210	176	79	regulatory	regulatory	ADJ
globalce-210	176	80	framework	framework	NOUN
globalce-210	176	81	for	for	ADP
globalce-210	176	82	medical	medical	ADJ
globalce-210	176	83	devices	device	NOUN
globalce-210	176	84	incorporating	incorporate	VERB
globalce-210	176	85	ai	ai	NOUN
globalce-210	176	86	is	be	AUX
globalce-210	176	87	currently	currently	ADV
globalce-210	176	88	experiencing	experience	VERB
globalce-210	176	89	substantial	substantial	ADJ
globalce-210	176	90	changes	change	NOUN
globalce-210	176	91	.	.	PUNCT
globalce-210	177	1	the	the	DET
globalce-210	177	2	ema	ema	PROPN
globalce-210	177	3	,	,	PUNCT
globalce-210	177	4	fda	fda	PROPN
globalce-210	177	5	,	,	PUNCT
globalce-210	177	6	and	and	CCONJ
globalce-210	177	7	cdsco	cdsco	PROPN
globalce-210	177	8	are	be	AUX
globalce-210	177	9	actively	actively	ADV
globalce-210	177	10	formulating	formulate	VERB
globalce-210	177	11	frameworks	framework	NOUN
globalce-210	177	12	and	and	CCONJ
globalce-210	177	13	guidelines	guideline	NOUN
globalce-210	177	14	to	to	PART
globalce-210	177	15	guarantee	guarantee	VERB
globalce-210	177	16	the	the	DET
globalce-210	177	17	secure	secure	ADJ
globalce-210	177	18	and	and	CCONJ
globalce-210	177	19	efficient	efficient	ADJ
globalce-210	177	20	utilization	utilization	NOUN
globalce-210	177	21	of	of	ADP
globalce-210	177	22	ai	ai	NOUN
globalce-210	177	23	.	.	PUNCT
globalce-210	178	1	these	these	DET
globalce-210	178	2	initiatives	initiative	NOUN
globalce-210	178	3	seek	seek	VERB
globalce-210	178	4	to	to	PART
globalce-210	178	5	tackle	tackle	VERB
globalce-210	178	6	problems	problem	NOUN
globalce-210	178	7	stemming	stem	VERB
globalce-210	178	8	from	from	ADP
globalce-210	178	9	unclear	unclear	ADJ
globalce-210	178	10	regulations	regulation	NOUN
globalce-210	178	11	and	and	CCONJ
globalce-210	178	12	a	a	DET
globalce-210	178	13	lack	lack	NOUN
globalce-210	178	14	of	of	ADP
globalce-210	178	15	expertise	expertise	NOUN
globalce-210	178	16	in	in	ADP
globalce-210	178	17	the	the	DET
globalce-210	178	18	field	field	NOUN
globalce-210	178	19	.	.	PUNCT
globalce-210	179	1	the	the	DET
globalce-210	179	2	ema	ema	PROPN
globalce-210	179	3	’s	’s	PART
globalce-210	179	4	reflection	reflection	NOUN
globalce-210	179	5	paper	paper	NOUN
globalce-210	179	6	emphasizes	emphasize	VERB
globalce-210	179	7	the	the	DET
globalce-210	179	8	importance	importance	NOUN
globalce-210	179	9	of	of	ADP
globalce-210	179	10	conducting	conduct	VERB
globalce-210	179	11	a	a	DET
globalce-210	179	12	thorough	thorough	ADJ
globalce-210	179	13	risk	risk	NOUN
globalce-210	179	14	analysis	analysis	NOUN
globalce-210	179	15	at	at	ADP
globalce-210	179	16	the	the	DET
globalce-210	179	17	time	time	NOUN
globalce-210	179	18	of	of	ADP
globalce-210	179	19	making	make	VERB
globalce-210	179	20	decisions	decision	NOUN
globalce-210	179	21	about	about	ADP
globalce-210	179	22	the	the	DET
globalce-210	179	23	implementation	implementation	NOUN
globalce-210	179	24	of	of	ADP
globalce-210	179	25	ai	ai	NOUN
globalce-210	179	26	in	in	ADP
globalce-210	179	27	medicines	medicine	NOUN
globalce-210	179	28	.	.	PUNCT
globalce-210	180	1	this	this	DET
globalce-210	180	2	analysis	analysis	NOUN
globalce-210	180	3	should	should	AUX
globalce-210	180	4	take	take	VERB
globalce-210	180	5	into	into	ADP
globalce-210	180	6	account	account	NOUN
globalce-210	180	7	factors	factor	NOUN
globalce-210	180	8	such	such	ADJ
globalce-210	180	9	as	as	ADP
globalce-210	180	10	the	the	DET
globalce-210	180	11	transparency	transparency	NOUN
globalce-210	180	12	and	and	CCONJ
globalce-210	180	13	interpretability	interpretability	NOUN
globalce-210	180	14	of	of	ADP
globalce-210	180	15	the	the	DET
globalce-210	180	16	ai	ai	NOUN
globalce-210	180	17	system	system	NOUN
globalce-210	180	18	as	as	ADV
globalce-210	180	19	well	well	ADV
globalce-210	180	20	as	as	ADP
globalce-210	180	21	its	its	PRON
globalce-210	180	22	ability	ability	NOUN
globalce-210	180	23	to	to	PART
globalce-210	180	24	manage	manage	VERB
globalce-210	180	25	changes	change	NOUN
globalce-210	180	26	throughout	throughout	ADP
globalce-210	180	27	its	its	PRON
globalce-210	180	28	lifecycle	lifecycle	NOUN
globalce-210	180	29	.	.	PUNCT
globalce-210	181	1	artificial	artificial	ADJ
globalce-210	181	2	intelligence	intelligence	NOUN
globalce-210	181	3	has	have	VERB
globalce-210	181	4	the	the	DET
globalce-210	181	5	capacity	capacity	NOUN
globalce-210	181	6	to	to	PART
globalce-210	181	7	completely	completely	ADV
globalce-210	181	8	transform	transform	VERB
globalce-210	181	9	the	the	DET
globalce-210	181	10	field	field	NOUN
globalce-210	181	11	of	of	ADP
globalce-210	181	12	drug	drug	NOUN
globalce-210	181	13	discovery	discovery	NOUN
globalce-210	181	14	and	and	CCONJ
globalce-210	181	15	regulatory	regulatory	ADJ
globalce-210	181	16	processes	process	NOUN
globalce-210	181	17	,	,	PUNCT
globalce-210	181	18	encompassing	encompass	VERB
globalce-210	181	19	everything	everything	PRON
globalce-210	181	20	from	from	ADP
globalce-210	181	21	the	the	DET
globalce-210	181	22	initial	initial	ADJ
globalce-210	181	23	development	development	NOUN
globalce-210	181	24	of	of	ADP
globalce-210	181	25	pharmaceuticals	pharmaceutical	NOUN
globalce-210	181	26	to	to	ADP
globalce-210	181	27	ongoing	ongoing	ADJ
globalce-210	181	28	monitoring	monitoring	NOUN
globalce-210	181	29	after	after	ADP
globalce-210	181	30	approval	approval	NOUN
globalce-210	181	31	.	.	PUNCT
globalce-210	182	1	the	the	DET
globalce-210	182	2	ema	ema	PROPN
globalce-210	182	3	undertakes	undertake	VERB
globalce-210	182	4	a	a	DET
globalce-210	182	5	comprehensive	comprehensive	ADJ
globalce-210	182	6	assessment	assessment	NOUN
globalce-210	182	7	of	of	ADP
globalce-210	182	8	these	these	DET
globalce-210	182	9	assertions	assertion	NOUN
globalce-210	182	10	.	.	PUNCT
globalce-210	183	1	furthermore	furthermore	ADV
globalce-210	183	2	,	,	PUNCT
globalce-210	183	3	the	the	DET
globalce-210	183	4	scientific	scientific	ADJ
globalce-210	183	5	validity	validity	NOUN
globalce-210	183	6	and	and	CCONJ
globalce-210	183	7	applicability	applicability	NOUN
globalce-210	183	8	of	of	ADP
globalce-210	183	9	medical	medical	ADJ
globalce-210	183	10	devices	device	NOUN
globalce-210	183	11	incorporating	incorporate	VERB
globalce-210	183	12	ai	ai	VERB
globalce-210	183	13	that	that	PRON
globalce-210	183	14	are	be	AUX
globalce-210	183	15	utilized	utilize	VERB
globalce-210	183	16	in	in	ADP
globalce-210	183	17	clinical	clinical	ADJ
globalce-210	183	18	trials	trial	NOUN
globalce-210	183	19	within	within	ADP
globalce-210	183	20	the	the	DET
globalce-210	183	21	eu	eu	PROPN
globalce-210	183	22	are	be	AUX
globalce-210	183	23	evaluated	evaluate	VERB
globalce-210	183	24	to	to	PART
globalce-210	183	25	ascertain	ascertain	VERB
globalce-210	183	26	their	their	PRON
globalce-210	183	27	effectiveness	effectiveness	NOUN
globalce-210	183	28	and	and	CCONJ
globalce-210	183	29	suitability	suitability	NOUN
globalce-210	183	30	in	in	ADP
globalce-210	183	31	all	all	DET
globalce-210	183	32	member	member	NOUN
globalce-210	183	33	states	state	NOUN
globalce-210	183	34	.	.	PUNCT
globalce-210	184	1	the	the	DET
globalce-210	184	2	ema	ema	PROPN
globalce-210	184	3	recommends	recommend	VERB
globalce-210	184	4	that	that	SCONJ
globalce-210	184	5	sponsors	sponsor	NOUN
globalce-210	184	6	assess	assess	VERB
globalce-210	184	7	the	the	DET
globalce-210	184	8	potential	potential	ADJ
globalce-210	184	9	hazards	hazard	NOUN
globalce-210	184	10	of	of	ADP
globalce-210	184	11	implementing	implement	VERB
globalce-210	184	12	new	new	ADJ
globalce-210	184	13	ai	ai	ADJ
globalce-210	184	14	systems	system	NOUN
globalce-210	184	15	on	on	ADP
globalce-210	184	16	patients	patient	NOUN
globalce-210	184	17	and	and	CCONJ
globalce-210	184	18	promptly	promptly	ADV
globalce-210	184	19	seek	seek	VERB
globalce-210	184	20	guidance	guidance	NOUN
globalce-210	184	21	from	from	ADP
globalce-210	184	22	the	the	DET
globalce-210	184	23	regulatory	regulatory	ADJ
globalce-210	184	24	body	body	NOUN
globalce-210	184	25	.	.	PUNCT
globalce-210	185	1	additional	additional	ADJ
globalce-210	185	2	suggestions	suggestion	NOUN
globalce-210	185	3	involve	involve	VERB
globalce-210	185	4	the	the	DET
globalce-210	185	5	creation	creation	NOUN
globalce-210	185	6	and	and	CCONJ
globalce-210	185	7	evaluation	evaluation	NOUN
globalce-210	185	8	of	of	ADP
globalce-210	185	9	ai	ai	PROPN
globalce-210	185	10	systems	system	NOUN
globalce-210	185	11	using	use	VERB
globalce-210	185	12	clear	clear	ADJ
globalce-210	185	13	and	and	CCONJ
globalce-210	185	14	well	well	ADV
globalce-210	185	15	-	-	PUNCT
globalce-210	185	16	documented	document	VERB
globalce-210	185	17	approaches	approach	NOUN
globalce-210	185	18	,	,	PUNCT
globalce-210	185	19	offering	offer	VERB
globalce-210	185	20	strong	strong	ADJ
globalce-210	185	21	justifications	justification	NOUN
globalce-210	185	22	for	for	ADP
globalce-210	185	23	ai	ai	PRON
globalce-210	185	24	implementation	implementation	NOUN
globalce-210	185	25	in	in	ADP
globalce-210	185	26	particular	particular	ADJ
globalce-210	185	27	situations	situation	NOUN
globalce-210	185	28	,	,	PUNCT
globalce-210	185	29	and	and	CCONJ
globalce-210	185	30	comprehending	comprehend	VERB
globalce-210	185	31	the	the	DET
globalce-210	185	32	accompanying	accompany	VERB
globalce-210	185	33	hazards	hazard	NOUN
globalce-210	185	34	and	and	CCONJ
globalce-210	185	35	constraints	constraint	NOUN
globalce-210	185	36	.	.	PUNCT
globalce-210	186	1	the	the	DET
globalce-210	186	2	fda	fda	PROPN
globalce-210	186	3	has	have	AUX
globalce-210	186	4	released	release	VERB
globalce-210	186	5	guidelines	guideline	NOUN
globalce-210	186	6	for	for	ADP
globalce-210	186	7	samd	samd	NOUN
globalce-210	186	8	that	that	PRON
globalce-210	186	9	employ	employ	VERB
globalce-210	186	10	ai	ai	NOUN
globalce-210	186	11	and	and	CCONJ
globalce-210	186	12	ml	ml	ADJ
globalce-210	186	13	.	.	PUNCT
globalce-210	187	1	these	these	DET
globalce-210	187	2	guidelines	guideline	NOUN
globalce-210	187	3	provide	provide	VERB
globalce-210	187	4	recommendations	recommendation	NOUN
globalce-210	187	5	for	for	ADP
globalce-210	187	6	effectively	effectively	ADV
globalce-210	187	7	utilizing	utilize	VERB
globalce-210	187	8	ml	ml	ADP
globalce-210	187	9	,	,	PUNCT
globalce-210	187	10	incorporating	incorporate	VERB
globalce-210	187	11	pre	pre	ADJ
globalce-210	187	12	-	-	ADJ
globalce-210	187	13	established	established	ADJ
globalce-210	187	14	change	change	NOUN
globalce-210	187	15	control	control	NOUN
globalce-210	187	16	systems	system	NOUN
globalce-210	187	17	,	,	PUNCT
globalce-210	187	18	and	and	CCONJ
globalce-210	187	19	guaranteeing	guarantee	VERB
globalce-210	187	20	the	the	DET
globalce-210	187	21	openness	openness	NOUN
globalce-210	187	22	of	of	ADP
globalce-210	187	23	data	datum	NOUN
globalce-210	187	24	and	and	CCONJ
globalce-210	187	25	algorithms	algorithm	NOUN
globalce-210	187	26	.	.	PUNCT
globalce-210	188	1	the	the	DET
globalce-210	188	2	fda	fda	PROPN
globalce-210	188	3	acknowledges	acknowledge	VERB
globalce-210	188	4	the	the	DET
globalce-210	188	5	revolutionary	revolutionary	ADJ
globalce-210	188	6	potential	potential	NOUN
globalce-210	188	7	of	of	ADP
globalce-210	188	8	ai	ai	NOUN
globalce-210	188	9	and	and	CCONJ
globalce-210	188	10	ml	ml	X
globalce-210	188	11	in	in	ADP
globalce-210	188	12	medical	medical	ADJ
globalce-210	188	13	devices	device	NOUN
globalce-210	188	14	while	while	SCONJ
globalce-210	188	15	recognizing	recognize	VERB
globalce-210	188	16	the	the	DET
globalce-210	188	17	distinct	distinct	ADJ
globalce-210	188	18	challenges	challenge	NOUN
globalce-210	188	19	posed	pose	VERB
globalce-210	188	20	by	by	ADP
globalce-210	188	21	them	they	PRON
globalce-210	188	22	.	.	PUNCT
globalce-210	189	1	the	the	DET
globalce-210	189	2	adoption	adoption	NOUN
globalce-210	189	3	of	of	ADP
globalce-210	189	4	the	the	DET
globalce-210	189	5	tplc	tplc	NOUN
globalce-210	189	6	approach	approach	NOUN
globalce-210	189	7	facilitates	facilitate	VERB
globalce-210	189	8	the	the	DET
globalce-210	189	9	ongoing	ongoing	ADJ
globalce-210	189	10	enhancement	enhancement	NOUN
globalce-210	189	11	and	and	CCONJ
globalce-210	189	12	progression	progression	NOUN
globalce-210	189	13	of	of	ADP
globalce-210	189	14	ai	ai	NOUN
globalce-210	189	15	/	/	SYM
globalce-210	189	16	ml	ml	NOUN
globalce-210	189	17	-	-	PUNCT
globalce-210	189	18	based	base	VERB
globalce-210	189	19	software	software	NOUN
globalce-210	189	20	as	as	ADP
globalce-210	189	21	medical	medical	ADJ
globalce-210	189	22	devices	device	NOUN
globalce-210	189	23	,	,	PUNCT
globalce-210	189	24	ensuring	ensure	VERB
globalce-210	189	25	the	the	DET
globalce-210	189	26	preservation	preservation	NOUN
globalce-210	189	27	of	of	ADP
globalce-210	189	28	safety	safety	NOUN
globalce-210	189	29	and	and	CCONJ
globalce-210	189	30	efficacy	efficacy	NOUN
globalce-210	189	31	throughout	throughout	ADP
globalce-210	189	32	all	all	DET
globalce-210	189	33	premarket	premarket	NOUN
globalce-210	189	34	review	review	NOUN
globalce-210	189	35	activities	activity	NOUN
globalce-210	189	36	.	.	PUNCT
globalce-210	190	1	the	the	DET
globalce-210	190	2	cdsco	cdsco	PROPN
globalce-210	190	3	has	have	AUX
globalce-210	190	4	implemented	implement	VERB
globalce-210	190	5	the	the	DET
globalce-210	190	6	regulations	regulation	NOUN
globalce-210	190	7	established	establish	VERB
globalce-210	190	8	by	by	ADP
globalce-210	190	9	the	the	DET
globalce-210	190	10	imdrf	imdrf	NOUN
globalce-210	190	11	,	,	PUNCT
globalce-210	190	12	encompassing	encompass	VERB
globalce-210	190	13	the	the	DET
globalce-210	190	14	risk	risk	NOUN
globalce-210	190	15	-	-	PUNCT
globalce-210	190	16	based	base	VERB
globalce-210	190	17	classification	classification	NOUN
globalce-210	190	18	system	system	NOUN
globalce-210	190	19	and	and	CCONJ
globalce-210	190	20	fundamental	fundamental	ADJ
globalce-210	190	21	principles	principle	NOUN
globalce-210	190	22	for	for	ADP
globalce-210	190	23	guaranteeing	guarantee	VERB
globalce-210	190	24	safety	safety	NOUN
globalce-210	190	25	and	and	CCONJ
globalce-210	190	26	performance	performance	NOUN
globalce-210	190	27	.	.	PUNCT
globalce-210	191	1	the	the	DET
globalce-210	191	2	cdsco	cdsco	PROPN
globalce-210	191	3	follows	follow	VERB
globalce-210	191	4	imdrf	imdrf	VERB
globalce-210	191	5	guidelines	guideline	NOUN
globalce-210	191	6	to	to	PART
globalce-210	191	7	ensure	ensure	VERB
globalce-210	191	8	the	the	DET
globalce-210	191	9	performance	performance	NOUN
globalce-210	191	10	and	and	CCONJ
globalce-210	191	11	safety	safety	NOUN
globalce-210	191	12	of	of	ADP
globalce-210	191	13	medical	medical	ADJ
globalce-210	191	14	devices	device	NOUN
globalce-210	191	15	and	and	CCONJ
globalce-210	191	16	ivds	ivds	NOUN
globalce-210	191	17	while	while	SCONJ
globalce-210	191	18	designing	design	VERB
globalce-210	191	19	and	and	CCONJ
globalce-210	191	20	restructuring	restructure	VERB
globalce-210	191	21	samd	samd	NOUN
globalce-210	191	22	.	.	PUNCT
globalce-210	192	1	indian	indian	ADJ
globalce-210	192	2	samd	samd	NOUN
globalce-210	192	3	must	must	AUX
globalce-210	192	4	adhere	adhere	VERB
globalce-210	192	5	to	to	ADP
globalce-210	192	6	global	global	ADJ
globalce-210	192	7	standards	standard	NOUN
globalce-210	192	8	,	,	PUNCT
globalce-210	192	9	including	include	VERB
globalce-210	192	10	iec	iec	PROPN
globalce-210	192	11	62304	62304	NUM
globalce-210	192	12	,	,	PUNCT
globalce-210	192	13	for	for	ADP
globalce-210	192	14	managing	manage	VERB
globalce-210	192	15	risks	risk	NOUN
globalce-210	192	16	in	in	ADP
globalce-210	192	17	the	the	DET
globalce-210	192	18	software	software	NOUN
globalce-210	192	19	life	life	NOUN
globalce-210	192	20	cycle	cycle	NOUN
globalce-210	192	21	,	,	PUNCT
globalce-210	192	22	iec	iec	PROPN
globalce-210	192	23	60601	60601	NUM
globalce-210	192	24	-	-	SYM
globalce-210	192	25	1	1	NUM
globalce-210	192	26	for	for	ADP
globalce-210	192	27	embedded	embed	VERB
globalce-210	192	28	software	software	NOUN
globalce-210	192	29	,	,	PUNCT
globalce-210	192	30	and	and	CCONJ
globalce-210	192	31	iec	iec	NOUN
globalce-210	192	32	82304	82304	NUM
globalce-210	192	33	-	-	SYM
globalce-210	192	34	1	1	NUM
globalce-210	192	35	for	for	ADP
globalce-210	192	36	standalone	standalone	ADJ
globalce-210	192	37	samd	samd	NOUN
globalce-210	192	38	.	.	PUNCT
globalce-210	193	1	although	although	SCONJ
globalce-210	193	2	regulatory	regulatory	ADJ
globalce-210	193	3	ambiguity	ambiguity	NOUN
globalce-210	193	4	and	and	CCONJ
globalce-210	193	5	limited	limited	ADJ
globalce-210	193	6	expertise	expertise	NOUN
globalce-210	193	7	pose	pose	VERB
globalce-210	193	8	significant	significant	ADJ
globalce-210	193	9	challenges	challenge	NOUN
globalce-210	193	10	,	,	PUNCT
globalce-210	193	11	these	these	DET
globalce-210	193	12	regulatory	regulatory	ADJ
globalce-210	193	13	bodies	body	NOUN
globalce-210	193	14	are	be	AUX
globalce-210	193	15	making	make	VERB
globalce-210	193	16	efforts	effort	NOUN
globalce-210	193	17	to	to	PART
globalce-210	193	18	ensure	ensure	VERB
globalce-210	193	19	the	the	DET
globalce-210	193	20	safe	safe	ADJ
globalce-210	193	21	and	and	CCONJ
globalce-210	193	22	effective	effective	ADJ
globalce-210	193	23	utilization	utilization	NOUN
globalce-210	193	24	of	of	ADP
globalce-210	193	25	ai	ai	VERB
globalce-210	193	26	in	in	ADP
globalce-210	193	27	medical	medical	ADJ
globalce-210	193	28	devices	device	NOUN
globalce-210	193	29	,	,	PUNCT
globalce-210	193	30	ultimately	ultimately	ADV
globalce-210	193	31	improving	improve	VERB
globalce-210	193	32	patient	patient	ADJ
globalce-210	193	33	outcomes	outcome	NOUN
globalce-210	193	34	.	.	PUNCT
globalce-210	194	1	the	the	DET
globalce-210	194	2	main	main	ADJ
globalce-210	194	3	goal	goal	NOUN
globalce-210	194	4	of	of	ADP
globalce-210	194	5	the	the	DET
globalce-210	194	6	eu	eu	PROPN
globalce-210	194	7	ai	ai	PROPN
globalce-210	194	8	act	act	NOUN
globalce-210	194	9	is	be	AUX
globalce-210	194	10	to	to	PART
globalce-210	194	11	effectively	effectively	ADV
globalce-210	194	12	govern	govern	VERB
globalce-210	194	13	scientific	scientific	ADJ
globalce-210	194	14	progress	progress	NOUN
globalce-210	194	15	and	and	CCONJ
globalce-210	194	16	the	the	DET
globalce-210	194	17	extensive	extensive	ADJ
globalce-210	194	18	implementation	implementation	NOUN
globalce-210	194	19	of	of	ADP
globalce-210	194	20	ai	ai	NOUN
globalce-210	194	21	in	in	ADP
globalce-210	194	22	medical	medical	ADJ
globalce-210	194	23	devices	device	NOUN
globalce-210	194	24	and	and	CCONJ
globalce-210	194	25	other	other	ADJ
globalce-210	194	26	products	product	NOUN
globalce-210	194	27	and	and	CCONJ
globalce-210	194	28	services	service	NOUN
globalce-210	194	29	.	.	PUNCT
globalce-210	195	1	these	these	DET
globalce-210	195	2	organizations	organization	NOUN
globalce-210	195	3	work	work	VERB
globalce-210	195	4	diligently	diligently	ADV
globalce-210	195	5	to	to	PART
globalce-210	195	6	ensure	ensure	VERB
globalce-210	195	7	that	that	SCONJ
globalce-210	195	8	ai	ai	VERB
globalce-210	195	9	systems	system	NOUN
globalce-210	195	10	comply	comply	VERB
globalce-210	195	11	with	with	ADP
globalce-210	195	12	safety	safety	NOUN
globalce-210	195	13	regulations	regulation	NOUN
globalce-210	195	14	and	and	CCONJ
globalce-210	195	15	ethical	ethical	ADJ
globalce-210	195	16	considerations	consideration	NOUN
globalce-210	195	17	while	while	SCONJ
globalce-210	195	18	also	also	ADV
globalce-210	195	19	protecting	protect	VERB
globalce-210	195	20	fundamental	fundamental	ADJ
globalce-210	195	21	rights	right	NOUN
globalce-210	195	22	.	.	PUNCT
globalce-210	196	1	author	author	NOUN
globalce-210	196	2	contributions	contribution	NOUN
globalce-210	196	3	conceptualization	conceptualization	NOUN
globalce-210	196	4	,	,	PUNCT
globalce-210	196	5	r.g	r.g	PROPN
globalce-210	196	6	.	.	PROPN
globalce-210	196	7	;	;	PUNCT
globalce-210	196	8	methodology	methodology	NOUN
globalce-210	196	9	,	,	PUNCT
globalce-210	196	10	s.b.c	s.b.c	PROPN
globalce-210	196	11	.	.	PUNCT
globalce-210	196	12	;	;	PUNCT
globalce-210	197	1	software	software	NOUN
globalce-210	197	2	,	,	PUNCT
globalce-210	197	3	i.s	i.s	PROPN
globalce-210	197	4	.	.	PROPN
globalce-210	197	5	;	;	PUNCT
globalce-210	197	6	validation	validation	NOUN
globalce-210	197	7	,	,	PUNCT
globalce-210	197	8	i.s	i.s	PROPN
globalce-210	197	9	.	.	PROPN
globalce-210	197	10	;	;	PUNCT
globalce-210	197	11	investigation	investigation	NOUN
globalce-210	197	12	,	,	PUNCT
globalce-210	197	13	s.b.c	s.b.c	PROPN
globalce-210	197	14	.	.	PUNCT
globalce-210	197	15	;	;	PUNCT
globalce-210	197	16	resources	resource	NOUN
globalce-210	197	17	,	,	PUNCT
globalce-210	197	18	i.s	i.s	PROPN
globalce-210	197	19	.	.	PROPN
globalce-210	197	20	;	;	PUNCT
globalce-210	197	21	data	datum	NOUN
globalce-210	197	22	curation	curation	NOUN
globalce-210	197	23	,	,	PUNCT
globalce-210	197	24	a.a	a.a	PROPN
globalce-210	197	25	.	.	PROPN
globalce-210	197	26	;	;	PUNCT
globalce-210	197	27	writing	write	VERB
globalce-210	197	28	–	–	PUNCT
globalce-210	197	29	original	original	ADJ
globalce-210	197	30	draft	draft	NOUN
globalce-210	197	31	preparation	preparation	NOUN
globalce-210	197	32	,	,	PUNCT
globalce-210	197	33	r.g	r.g	PROPN
globalce-210	197	34	.	.	PROPN
globalce-210	197	35	and	and	CCONJ
globalce-210	197	36	a.a	a.a	PROPN
globalce-210	197	37	.	.	PROPN
globalce-210	197	38	;	;	PUNCT
globalce-210	197	39	writing	write	VERB
globalce-210	197	40	–	–	PUNCT
globalce-210	197	41	review	review	NOUN
globalce-210	197	42	&	&	CCONJ
globalce-210	197	43	editing	editing	PROPN
globalce-210	197	44	,	,	PUNCT
globalce-210	197	45	s.b.c	s.b.c	NOUN
globalce-210	197	46	.	.	PUNCT
globalce-210	197	47	;	;	PUNCT
globalce-210	198	1	visualization	visualization	NOUN
globalce-210	198	2	,	,	PUNCT
globalce-210	198	3	s.b.c	s.b.c	NOUN
globalce-210	198	4	.	.	PUNCT
globalce-210	198	5	;	;	PUNCT
globalce-210	198	6	supervision	supervision	NOUN
globalce-210	198	7	,	,	PUNCT
globalce-210	198	8	i.s	i.s	PROPN
globalce-210	198	9	.	.	PROPN
globalce-210	198	10	;	;	PUNCT
globalce-210	198	11	project	project	NOUN
globalce-210	198	12	administration	administration	NOUN
globalce-210	198	13	,	,	PUNCT
globalce-210	198	14	i.s	i.s	PROPN
globalce-210	198	15	.	.	PUNCT
globalce-210	198	16	acknowledgments	acknowledgment	NOUN
globalce-210	199	1	the	the	DET
globalce-210	199	2	technical	technical	ADJ
globalce-210	199	3	assistance	assistance	NOUN
globalce-210	199	4	needed	need	VERB
globalce-210	199	5	to	to	PART
globalce-210	199	6	finish	finish	VERB
globalce-210	199	7	this	this	DET
globalce-210	199	8	project	project	NOUN
globalce-210	199	9	was	be	AUX
globalce-210	199	10	provided	provide	VERB
globalce-210	199	11	by	by	ADP
globalce-210	199	12	amity	amity	NOUN
globalce-210	199	13	institute	institute	NOUN
globalce-210	199	14	of	of	ADP
globalce-210	199	15	pharmacy	pharmacy	NOUN
globalce-210	199	16	at	at	ADP
globalce-210	199	17	amity	amity	PROPN
globalce-210	199	18	university	university	PROPN
globalce-210	199	19	noida	noida	PROPN
globalce-210	199	20	,	,	PUNCT
globalce-210	199	21	for	for	ADP
globalce-210	199	22	which	which	PRON
globalce-210	199	23	the	the	DET
globalce-210	199	24	authors	author	NOUN
globalce-210	199	25	are	be	AUX
globalce-210	199	26	grateful	grateful	ADJ
globalce-210	199	27	.	.	PUNCT
globalce-210	200	1	funding	fund	VERB
globalce-210	200	2	this	this	DET
globalce-210	200	3	research	research	NOUN
globalce-210	200	4	received	receive	VERB
globalce-210	200	5	no	no	DET
globalce-210	200	6	external	external	ADJ
globalce-210	200	7	funding	funding	NOUN
globalce-210	200	8	.	.	PUNCT
globalce-210	201	1	data	datum	NOUN
globalce-210	201	2	availability	availability	NOUN
globalce-210	201	3	statement	statement	NOUN
globalce-210	201	4	not	not	PART
globalce-210	201	5	applicable	applicable	ADJ
globalce-210	201	6	.	.	PUNCT
globalce-210	202	1	conflicts	conflict	NOUN
globalce-210	202	2	of	of	ADP
globalce-210	202	3	interest	interest	NOUN
globalce-210	202	4	the	the	DET
globalce-210	202	5	authors	author	NOUN
globalce-210	202	6	declare	declare	VERB
globalce-210	202	7	they	they	PRON
globalce-210	202	8	have	have	VERB
globalce-210	202	9	no	no	DET
globalce-210	202	10	competing	compete	VERB
globalce-210	202	11	interests	interest	NOUN
globalce-210	202	12	.	.	PUNCT
globalce-210	203	1	gaur	gaur	PROPN
globalce-210	203	2	,	,	PUNCT
globalce-210	203	3	akram	akram	PROPN
globalce-210	203	4	,	,	PUNCT
globalce-210	203	5	singh	singh	PROPN
globalce-210	203	6	,	,	PUNCT
globalce-210	203	7	chauhan	chauhan	PROPN
globalce-210	203	8	:	:	PUNCT
globalce-210	203	9	artificial	artificial	ADJ
globalce-210	203	10	intelligence	intelligence	NOUN
globalce-210	203	11	-	-	PUNCT
globalce-210	203	12	driven	drive	VERB
globalce-210	203	13	insights	insight	NOUN
globalce-210	203	14	for	for	ADP
globalce-210	203	15	regulatory	regulatory	ADJ
globalce-210	203	16	intelligence	intelligence	NOUN
globalce-210	203	17	in	in	ADP
globalce-210	203	18	medical	medical	ADJ
globalce-210	203	19	devices	device	NOUN
globalce-210	203	20	:	:	PUNCT
globalce-210	203	21	evaluating	evaluate	VERB
globalce-210	203	22	ema	ema	PROPN
globalce-210	203	23	,	,	PUNCT
globalce-210	203	24	fda	fda	PROPN
globalce-210	203	25	,	,	PUNCT
globalce-210	203	26	and	and	CCONJ
globalce-210	203	27	cdsco	cdsco	PROPN
globalce-210	203	28	frameworks	framework	VERB
globalce-210	203	29	j	j	PROPN
globalce-210	203	30	global	global	ADJ
globalce-210	203	31	clinical	clinical	ADJ
globalce-210	203	32	engineering	engineering	NOUN
globalce-210	203	33	vol.7	vol.7	PROPN
globalce-210	203	34	issue	issue	NOUN
globalce-210	203	35	2	2	NUM
globalce-210	203	36	:	:	SYM
globalce-210	203	37	2025	2025	NUM
globalce-210	203	38	22	22	NUM
globalce-210	203	39	ethics	ethic	NOUN
globalce-210	203	40	approval	approval	NOUN
globalce-210	203	41	and	and	CCONJ
globalce-210	203	42	consent	consent	NOUN
globalce-210	203	43	to	to	PART
globalce-210	203	44	participate	participate	VERB
globalce-210	203	45	not	not	PART
globalce-210	203	46	applicable	applicable	ADJ
globalce-210	203	47	.	.	PUNCT
globalce-210	204	1	consent	consent	NOUN
globalce-210	204	2	for	for	ADP
globalce-210	204	3	publication	publication	NOUN
globalce-210	204	4	not	not	PART
globalce-210	204	5	applicable	applicable	ADJ
globalce-210	204	6	.	.	PUNCT
globalce-210	205	1	further	further	ADJ
globalce-210	205	2	disclosure	disclosure	NOUN
globalce-210	205	3	not	not	PART
globalce-210	205	4	applicable	applicable	ADJ
globalce-210	205	5	.	.	PUNCT
globalce-210	206	1	references	reference	NOUN
globalce-210	206	2	1	1	NUM
globalce-210	206	3	.	.	PUNCT
globalce-210	207	1	ai	ai	VERB
globalce-210	207	2	:	:	PUNCT
globalce-210	207	3	upcoming	upcoming	ADJ
globalce-210	207	4	regulations	regulation	NOUN
globalce-210	207	5	for	for	ADP
globalce-210	207	6	pharma	pharma	NOUN
globalce-210	207	7	and	and	CCONJ
globalce-210	207	8	medical	medical	ADJ
globalce-210	207	9	devices	device	NOUN
globalce-210	207	10	.	.	PUNCT
globalce-210	208	1	available	available	ADJ
globalce-210	208	2	online	online	ADV
globalce-210	208	3	:	:	PUNCT
globalce-210	209	1	https://www.scilife.io/blog/	https://www.scilife.io/blog/	PROPN
globalce-210	209	2	artificial	artificial	ADJ
globalce-210	209	3	-	-	PUNCT
globalce-210	209	4	intelligence	intelligence	NOUN
globalce-210	209	5	-	-	PUNCT
globalce-210	209	6	regulations	regulation	NOUN
globalce-210	209	7	.	.	PUNCT
globalce-210	210	1	2	2	X
globalce-210	210	2	.	.	X
globalce-210	210	3	food	food	NOUN
globalce-210	210	4	and	and	CCONJ
globalce-210	210	5	drug	drug	PROPN
globalce-210	210	6	administration	administration	PROPN
globalce-210	210	7	(	(	PUNCT
globalce-210	210	8	fda	fda	PROPN
globalce-210	210	9	)	)	PUNCT
globalce-210	210	10	.	.	PUNCT
globalce-210	211	1	artificial	artificial	ADJ
globalce-210	211	2	intelligence	intelligence	NOUN
globalce-210	211	3	and	and	CCONJ
globalce-210	211	4	machine	machine	NOUN
globalce-210	211	5	learning	learn	VERB
globalce-210	211	6	in	in	ADP
globalce-210	211	7	software	software	NOUN
globalce-210	211	8	as	as	ADP
globalce-210	211	9	a	a	DET
globalce-210	211	10	medical	medical	ADJ
globalce-210	211	11	device	device	NOUN
globalce-210	211	12	.	.	PUNCT
globalce-210	212	1	available	available	ADJ
globalce-210	212	2	online	online	ADV
globalce-210	212	3	:	:	PUNCT
globalce-210	213	1	https://www.fda	https://www.fda	PROPN
globalce-210	213	2	.	.	PUNCT
globalce-210	214	1	gov	gov	PROPN
globalce-210	214	2	/	/	SYM
globalce-210	214	3	medical	medical	ADJ
globalce-210	214	4	-	-	PUNCT
globalce-210	214	5	devices	device	NOUN
globalce-210	214	6	/	/	SYM
globalce-210	214	7	software	software	NOUN
globalce-210	214	8	-	-	PUNCT
globalce-210	214	9	medical	medical	ADJ
globalce-210	214	10	-	-	PUNCT
globalce-210	214	11	device	device	NOUN
globalce-210	214	12	-	-	PUNCT
globalce-210	214	13	samd/	samd/	NUM
globalce-210	214	14	artificial	artificial	ADJ
globalce-210	214	15	-	-	PUNCT
globalce-210	214	16	intelligence	intelligence	NOUN
globalce-210	214	17	-	-	PUNCT
globalce-210	214	18	and	and	CCONJ
globalce-210	214	19	-	-	PUNCT
globalce-210	214	20	machine	machine	NOUN
globalce-210	214	21	-	-	PUNCT
globalce-210	214	22	learning	learning	NOUN
globalce-210	214	23	-	-	PUNCT
globalce-210	214	24	softwaremedical	softwaremedical	ADJ
globalce-210	214	25	-	-	PUNCT
globalce-210	214	26	device	device	NOUN
globalce-210	214	27	.	.	PUNCT
globalce-210	215	1	3	3	X
globalce-210	215	2	.	.	X
globalce-210	215	3	shick	shick	PROPN
globalce-210	215	4	,	,	PUNCT
globalce-210	215	5	a.a	a.a	PROPN
globalce-210	215	6	.	.	PROPN
globalce-210	215	7	,	,	PUNCT
globalce-210	215	8	webber	webber	PROPN
globalce-210	215	9	,	,	PUNCT
globalce-210	215	10	c.m	c.m	PROPN
globalce-210	215	11	.	.	PROPN
globalce-210	215	12	,	,	PUNCT
globalce-210	215	13	kiarashi	kiarashi	PROPN
globalce-210	215	14	,	,	PUNCT
globalce-210	215	15	n.	n.	NOUN
globalce-210	215	16	,	,	PUNCT
globalce-210	215	17	et	et	PROPN
globalce-210	215	18	al	al	PROPN
globalce-210	215	19	.	.	PUNCT
globalce-210	215	20	transparency	transparency	NOUN
globalce-210	215	21	of	of	ADP
globalce-210	215	22	artificial	artificial	ADJ
globalce-210	215	23	intelligence	intelligence	NOUN
globalce-210	215	24	/	/	SYM
globalce-210	215	25	machine	machine	NOUN
globalce-210	215	26	learning	learning	NOUN
globalce-210	215	27	-	-	PUNCT
globalce-210	215	28	enabled	enable	VERB
globalce-210	215	29	medical	medical	ADJ
globalce-210	215	30	devices	device	NOUN
globalce-210	215	31	.	.	PUNCT
globalce-210	216	1	npj	npj	NOUN
globalce-210	216	2	digit	digit	NOUN
globalce-210	216	3	med	med	PROPN
globalce-210	216	4	.	.	PUNCT
globalce-210	217	1	2024;7(1):21	2024;7(1):21	NUM
globalce-210	217	2	.	.	PUNCT
globalce-210	218	1	https://	https://	PROPN
globalce-210	218	2	doi.org/10.1038/s41746-023-00992-8	doi.org/10.1038/s41746-023-00992-8	PROPN
globalce-210	218	3	.	.	PUNCT
globalce-210	219	1	4	4	X
globalce-210	219	2	.	.	X
globalce-210	219	3	parenteral	parenteral	ADJ
globalce-210	219	4	drug	drug	NOUN
globalce-210	219	5	association	association	NOUN
globalce-210	219	6	(	(	PUNCT
globalce-210	219	7	pda	pda	NOUN
globalce-210	219	8	)	)	PUNCT
globalce-210	219	9	.	.	PUNCT
globalce-210	220	1	a	a	DET
globalce-210	220	2	comprehensive	comprehensive	ADJ
globalce-210	220	3	review	review	NOUN
globalce-210	220	4	of	of	ADP
globalce-210	220	5	regulatory	regulatory	ADJ
globalce-210	220	6	intelligence	intelligence	NOUN
globalce-210	220	7	:	:	PUNCT
globalce-210	220	8	exploring	explore	VERB
globalce-210	220	9	tools	tool	NOUN
globalce-210	220	10	and	and	CCONJ
globalce-210	220	11	program	program	NOUN
globalce-210	220	12	maturities	maturity	NOUN
globalce-210	220	13	.	.	PUNCT
globalce-210	221	1	available	available	ADJ
globalce-210	221	2	online	online	ADV
globalce-210	221	3	:	:	PUNCT
globalce-210	221	4	https://	https://	PROPN
globalce-210	221	5	www.pda.org/pda-letter-portal/home/full-article/acomprehensive-review-of-regulatory-intelligenceexploring-tools-and-program-maturities	www.pda.org/pda-letter-portal/home/full-article/acomprehensive-review-of-regulatory-intelligenceexploring-tools-and-program-maturitie	NOUN
globalce-210	221	6	.	.	PUNCT
globalce-210	222	1	5	5	X
globalce-210	222	2	.	.	X
globalce-210	222	3	koli	koli	PROPN
globalce-210	222	4	,	,	PUNCT
globalce-210	222	5	p.	p.	PROPN
globalce-210	222	6	,	,	PUNCT
globalce-210	222	7	raut	raut	PROPN
globalce-210	222	8	,	,	PUNCT
globalce-210	222	9	s.	s.	PROPN
globalce-210	222	10	,	,	PUNCT
globalce-210	222	11	mande	mande	PROPN
globalce-210	222	12	,	,	PUNCT
globalce-210	222	13	r.	r.	PROPN
globalce-210	222	14	,	,	PUNCT
globalce-210	222	15	et	et	PROPN
globalce-210	222	16	al	al	PROPN
globalce-210	222	17	.	.	PUNCT
globalce-210	223	1	an	an	DET
globalce-210	223	2	overview	overview	NOUN
globalce-210	223	3	of	of	ADP
globalce-210	223	4	regulatory	regulatory	ADJ
globalce-210	223	5	intelligence	intelligence	NOUN
globalce-210	223	6	.	.	PUNCT
globalce-210	224	1	int	int	PROPN
globalce-210	224	2	j	j	PROPN
globalce-210	224	3	creat	creat	NOUN
globalce-210	224	4	res	re	NOUN
globalce-210	224	5	thoughts	thought	NOUN
globalce-210	224	6	.	.	PUNCT
globalce-210	225	1	2023;11(4):b953	2023;11(4):b953	X
globalce-210	225	2	–	–	PUNCT
globalce-210	225	3	b964	b964	PROPN
globalce-210	225	4	.	.	PUNCT
globalce-210	226	1	http://ijcrt.org/viewfull	http://ijcrt.org/viewfull	PROPN
globalce-210	226	2	.	.	PUNCT
globalce-210	227	1	php?&p_id	php?&p_id	PROPN
globalce-210	227	2	=	=	SYM
globalce-210	227	3	ijcrt2304232	ijcrt2304232	PROPN
globalce-210	227	4	.	.	PROPN
globalce-210	228	1	6	6	NUM
globalce-210	228	2	.	.	X
globalce-210	228	3	zhou	zhou	PROPN
globalce-210	228	4	,	,	PUNCT
globalce-210	228	5	k.	k.	PROPN
globalce-210	228	6	and	and	CCONJ
globalce-210	228	7	gattinger	gattinger	NOUN
globalce-210	228	8	,	,	PUNCT
globalce-210	228	9	g.	g.	PROPN
globalce-210	228	10	the	the	DET
globalce-210	228	11	evolving	evolve	VERB
globalce-210	228	12	regulatory	regulatory	ADJ
globalce-210	228	13	paradigm	paradigm	NOUN
globalce-210	228	14	of	of	ADP
globalce-210	228	15	ai	ai	NOUN
globalce-210	228	16	in	in	ADP
globalce-210	228	17	med	med	ADJ
globalce-210	228	18	tech	tech	NOUN
globalce-210	228	19	:	:	PUNCT
globalce-210	228	20	a	a	DET
globalce-210	228	21	review	review	NOUN
globalce-210	228	22	of	of	ADP
globalce-210	228	23	perspectives	perspective	NOUN
globalce-210	228	24	and	and	CCONJ
globalce-210	228	25	where	where	SCONJ
globalce-210	228	26	we	we	PRON
globalce-210	228	27	are	be	AUX
globalce-210	228	28	today	today	NOUN
globalce-210	228	29	.	.	PUNCT
globalce-210	229	1	ther	ther	PROPN
globalce-210	229	2	innov	innov	PROPN
globalce-210	229	3	regul	regul	PROPN
globalce-210	229	4	sci	sci	PROPN
globalce-210	229	5	.	.	PUNCT
globalce-210	230	1	2024;58(3):456–464	2024;58(3):456–464	ADV
globalce-210	230	2	.	.	PUNCT
globalce-210	231	1	https://doi.org/10.1007/	https://doi.org/10.1007/	PROPN
globalce-210	231	2	s43441	s43441	PROPN
globalce-210	231	3	-	-	PUNCT
globalce-210	231	4	024	024	NUM
globalce-210	231	5	-	-	PUNCT
globalce-210	231	6	00628	00628	NUM
globalce-210	231	7	-	-	SYM
globalce-210	231	8	3	3	NUM
globalce-210	231	9	.	.	NOUN
globalce-210	231	10	7	7	NUM
globalce-210	231	11	.	.	X
globalce-210	231	12	wenzel	wenzel	PROPN
globalce-210	231	13	,	,	PUNCT
globalce-210	231	14	m.	m.	NOUN
globalce-210	231	15	and	and	CCONJ
globalce-210	231	16	wiegand	wiegand	NOUN
globalce-210	231	17	,	,	PUNCT
globalce-210	231	18	t.	t.	NOUN
globalce-210	231	19	toward	toward	ADP
globalce-210	231	20	global	global	ADJ
globalce-210	231	21	validation	validation	NOUN
globalce-210	231	22	standards	standard	NOUN
globalce-210	231	23	for	for	ADP
globalce-210	231	24	health	health	NOUN
globalce-210	231	25	ai	ai	NOUN
globalce-210	231	26	.	.	PUNCT
globalce-210	231	27	ieee	ieee	PROPN
globalce-210	231	28	commun	commun	PROPN
globalce-210	231	29	stand	stand	VERB
globalce-210	231	30	mag	mag	PROPN
globalce-210	231	31	.	.	PUNCT
globalce-210	232	1	2020;4(3):64–69	2020;4(3):64–69	X
globalce-210	232	2	.	.	PUNCT
globalce-210	233	1	https://doi.org/10.1109/	https://doi.org/10.1109/	PROPN
globalce-210	233	2	mcomstd.001.2000006	mcomstd.001.2000006	NOUN
globalce-210	233	3	.	.	PROPN
globalce-210	233	4	8	8	NUM
globalce-210	233	5	.	.	X
globalce-210	234	1	rajkomar	rajkomar	PROPN
globalce-210	234	2	,	,	PUNCT
globalce-210	234	3	a.	a.	NOUN
globalce-210	234	4	,	,	PUNCT
globalce-210	234	5	dean	dean	PROPN
globalce-210	234	6	,	,	PUNCT
globalce-210	234	7	j.	j.	PROPN
globalce-210	234	8	,	,	PUNCT
globalce-210	234	9	kohane	kohane	PROPN
globalce-210	234	10	,	,	PUNCT
globalce-210	234	11	i.	i.	NOUN
globalce-210	234	12	machine	machine	NOUN
globalce-210	234	13	learning	learn	VERB
globalce-210	234	14	in	in	ADP
globalce-210	234	15	medicine	medicine	NOUN
globalce-210	234	16	.	.	PUNCT
globalce-210	235	1	n	n	PRON
globalce-210	235	2	engl	engl	PROPN
globalce-210	235	3	j	j	PROPN
globalce-210	235	4	med	med	PROPN
globalce-210	235	5	.	.	PUNCT
globalce-210	236	1	2019;380(14):1347–1358	2019;380(14):1347–1358	NUM
globalce-210	236	2	.	.	PUNCT
globalce-210	237	1	https://doi.org/10.1056/nejmra1814259	https://doi.org/10.1056/nejmra1814259	PROPN
globalce-210	237	2	.	.	PUNCT
globalce-210	238	1	9	9	X
globalce-210	238	2	.	.	X
globalce-210	238	3	wenzel	wenzel	PROPN
globalce-210	238	4	,	,	PUNCT
globalce-210	238	5	m.a	m.a	PROPN
globalce-210	238	6	.	.	PROPN
globalce-210	238	7	and	and	CCONJ
globalce-210	238	8	wiegand	wiegand	NOUN
globalce-210	238	9	,	,	PUNCT
globalce-210	238	10	t.	t.	PROPN
globalce-210	238	11	towards	towards	ADP
globalce-210	238	12	international	international	ADJ
globalce-210	238	13	standards	standard	NOUN
globalce-210	238	14	for	for	ADP
globalce-210	238	15	the	the	DET
globalce-210	238	16	evaluation	evaluation	NOUN
globalce-210	238	17	of	of	ADP
globalce-210	238	18	artificial	artificial	ADJ
globalce-210	238	19	intelligence	intelligence	NOUN
globalce-210	238	20	for	for	ADP
globalce-210	238	21	health	health	NOUN
globalce-210	238	22	.	.	PUNCT
globalce-210	239	1	in	in	ADP
globalce-210	239	2	2019	2019	NUM
globalce-210	239	3	itu	itu	PROPN
globalce-210	239	4	kaleidoscope	kaleidoscope	NOUN
globalce-210	239	5	:	:	PUNCT
globalce-210	239	6	ict	ict	PROPN
globalce-210	239	7	for	for	ADP
globalce-210	239	8	health	health	NOUN
globalce-210	239	9	:	:	PUNCT
globalce-210	239	10	networks	network	NOUN
globalce-210	239	11	,	,	PUNCT
globalce-210	239	12	standards	standard	NOUN
globalce-210	239	13	and	and	CCONJ
globalce-210	239	14	innovation	innovation	NOUN
globalce-210	239	15	(	(	PUNCT
globalce-210	239	16	itu	itu	PROPN
globalce-210	239	17	k	k	PROPN
globalce-210	239	18	)	)	PUNCT
globalce-210	239	19	,	,	PUNCT
globalce-210	239	20	atlanta	atlanta	PROPN
globalce-210	239	21	,	,	PUNCT
globalce-210	239	22	ga	ga	PROPN
globalce-210	239	23	,	,	PUNCT
globalce-210	239	24	usa	usa	PROPN
globalce-210	239	25	,	,	PUNCT
globalce-210	239	26	04–06	04–06	NUM
globalce-210	239	27	december	december	PROPN
globalce-210	239	28	2019	2019	NUM
globalce-210	239	29	;	;	PUNCT
globalce-210	239	30	ieee	ieee	NOUN
globalce-210	239	31	xplore	xplore	PROPN
globalce-210	239	32	:	:	PUNCT
globalce-210	239	33	piscateville	piscateville	PROPN
globalce-210	239	34	,	,	PUNCT
globalce-210	239	35	new	new	PROPN
globalce-210	239	36	jersey	jersey	PROPN
globalce-210	239	37	,	,	PUNCT
globalce-210	239	38	usa	usa	PROPN
globalce-210	239	39	.	.	PROPN
globalce-210	239	40	10	10	NUM
globalce-210	239	41	.	.	PUNCT
globalce-210	239	42	european	european	ADJ
globalce-210	239	43	parliament	parliament	PROPN
globalce-210	239	44	.	.	PUNCT
globalce-210	240	1	eu	eu	PROPN
globalce-210	240	2	ai	ai	PROPN
globalce-210	240	3	act	act	PROPN
globalce-210	240	4	:	:	PUNCT
globalce-210	240	5	first	first	ADJ
globalce-210	240	6	regulation	regulation	NOUN
globalce-210	240	7	on	on	ADP
globalce-210	240	8	artificial	artificial	ADJ
globalce-210	240	9	intelligence	intelligence	NOUN
globalce-210	240	10	2013	2013	NUM
globalce-210	240	11	.	.	PUNCT
globalce-210	241	1	available	available	ADJ
globalce-210	241	2	online	online	ADV
globalce-210	241	3	:	:	PUNCT
globalce-210	242	1	https://www	https://www	PROPN
globalce-210	242	2	.	.	PUNCT
globalce-210	242	3	europarl.europa.eu/topics/en/article/20230601sto93804/	europarl.europa.eu/topics/en/article/20230601sto93804/	NUM
globalce-210	242	4	eu	eu	PROPN
globalce-210	242	5	-	-	PUNCT
globalce-210	242	6	ai	ai	ADJ
globalce-210	242	7	-	-	PUNCT
globalce-210	242	8	act	act	NOUN
globalce-210	242	9	-	-	PUNCT
globalce-210	242	10	first	first	ADJ
globalce-210	242	11	-	-	PUNCT
globalce-210	242	12	regulation	regulation	NOUN
globalce-210	242	13	-	-	PUNCT
globalce-210	242	14	on	on	ADP
globalce-210	242	15	-	-	PUNCT
globalce-210	242	16	artificial	artificial	ADJ
globalce-210	242	17	-	-	PUNCT
globalce-210	242	18	intelligence	intelligence	NOUN
globalce-210	242	19	.	.	PUNCT
globalce-210	243	1	11	11	NUM
globalce-210	243	2	.	.	PUNCT
globalce-210	244	1	european	european	PROPN
globalce-210	244	2	medicines	medicine	NOUN
globalce-210	244	3	agency	agency	NOUN
globalce-210	244	4	(	(	PUNCT
globalce-210	244	5	ema	ema	PROPN
globalce-210	244	6	)	)	PUNCT
globalce-210	244	7	.	.	PUNCT
globalce-210	245	1	artificial	artificial	ADJ
globalce-210	245	2	intelligence	intelligence	NOUN
globalce-210	245	3	workplan	workplan	NOUN
globalce-210	245	4	to	to	PART
globalce-210	245	5	guide	guide	VERB
globalce-210	245	6	use	use	NOUN
globalce-210	245	7	of	of	ADP
globalce-210	245	8	ai	ai	VERB
globalce-210	245	9	in	in	ADP
globalce-210	245	10	medicines	medicine	NOUN
globalce-210	245	11	regulation	regulation	NOUN
globalce-210	245	12	.	.	PUNCT
globalce-210	246	1	available	available	ADJ
globalce-210	246	2	online	online	ADV
globalce-210	246	3	:	:	PUNCT
globalce-210	246	4	https://www.ema.europa.eu/en/	https://www.ema.europa.eu/en/	NOUN
globalce-210	246	5	news	news	NOUN
globalce-210	246	6	/	/	SYM
globalce-210	246	7	artificial	artificial	ADJ
globalce-210	246	8	-	-	PUNCT
globalce-210	246	9	intelligence	intelligence	NOUN
globalce-210	246	10	-	-	PUNCT
globalce-210	246	11	workplan	workplan	NOUN
globalce-210	246	12	-	-	PUNCT
globalce-210	246	13	guide	guide	NOUN
globalce-210	246	14	-	-	PUNCT
globalce-210	246	15	use	use	NOUN
globalce-210	246	16	-	-	PUNCT
globalce-210	246	17	aimedicines	aimedicine	NOUN
globalce-210	246	18	-	-	PUNCT
globalce-210	246	19	regulation	regulation	NOUN
globalce-210	246	20	.	.	PUNCT
globalce-210	247	1	12	12	NUM
globalce-210	247	2	.	.	X
globalce-210	247	3	muehlematter	muehlematter	PROPN
globalce-210	247	4	,	,	PUNCT
globalce-210	247	5	u.j	u.j	PROPN
globalce-210	247	6	.	.	PROPN
globalce-210	247	7	,	,	PUNCT
globalce-210	247	8	daniore	daniore	ADV
globalce-210	247	9	,	,	PUNCT
globalce-210	247	10	p.	p.	NOUN
globalce-210	247	11	,	,	PUNCT
globalce-210	247	12	vokinger	vokinger	NOUN
globalce-210	247	13	,	,	PUNCT
globalce-210	247	14	k.n	k.n	PROPN
globalce-210	247	15	.	.	PROPN
globalce-210	247	16	approval	approval	NOUN
globalce-210	247	17	of	of	ADP
globalce-210	247	18	artificial	artificial	ADJ
globalce-210	247	19	intelligence	intelligence	NOUN
globalce-210	247	20	and	and	CCONJ
globalce-210	247	21	machine	machine	NOUN
globalce-210	247	22	learning	learning	NOUN
globalce-210	247	23	-	-	PUNCT
globalce-210	247	24	based	base	VERB
globalce-210	247	25	medical	medical	ADJ
globalce-210	247	26	devices	device	NOUN
globalce-210	247	27	in	in	ADP
globalce-210	247	28	the	the	DET
globalce-210	247	29	usa	usa	PROPN
globalce-210	247	30	and	and	CCONJ
globalce-210	247	31	europe	europe	PROPN
globalce-210	247	32	(	(	PUNCT
globalce-210	247	33	2015–20	2015–20	NOUN
globalce-210	247	34	):	):	PUNCT
globalce-210	247	35	a	a	DET
globalce-210	247	36	comparative	comparative	ADJ
globalce-210	247	37	analysis	analysis	NOUN
globalce-210	247	38	.	.	PUNCT
globalce-210	248	1	lancet	lancet	NOUN
globalce-210	248	2	digit	digit	NOUN
globalce-210	248	3	health	health	NOUN
globalce-210	248	4	.	.	PUNCT
globalce-210	249	1	2021;3(3):e195	2021;3(3):e195	PROPN
globalce-210	249	2	–	–	PUNCT
globalce-210	249	3	e203	e203	NUM
globalce-210	249	4	.	.	PUNCT
globalce-210	250	1	https://doi.org/10.1016/s2589-7500(20)30292-2	https://doi.org/10.1016/s2589-7500(20)30292-2	PROPN
globalce-210	250	2	.	.	PUNCT
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globalce-210	251	2	.	.	PUNCT
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globalce-210	251	4	,	,	PUNCT
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globalce-210	251	6	and	and	CCONJ
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globalce-210	251	8	,	,	PUNCT
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globalce-210	251	10	ai	ai	AUX
globalce-210	251	11	-	-	PUNCT
globalce-210	251	12	based	base	VERB
globalce-210	251	13	medical	medical	ADJ
globalce-210	251	14	devices	device	NOUN
globalce-210	251	15	and	and	CCONJ
globalce-210	251	16	regulations	regulation	NOUN
globalce-210	251	17	:	:	PUNCT
globalce-210	251	18	a	a	DET
globalce-210	251	19	cross	cross	ADJ
globalce-210	251	20	-	-	ADJ
globalce-210	251	21	country	country	ADJ
globalce-210	251	22	perspective	perspective	NOUN
globalce-210	251	23	.	.	PUNCT
globalce-210	252	1	in	in	ADP
globalce-210	252	2	artificial	artificial	ADJ
globalce-210	252	3	intelligence	intelligence	NOUN
globalce-210	252	4	in	in	ADP
globalce-210	252	5	drug	drug	NOUN
globalce-210	252	6	development	development	NOUN
globalce-210	252	7	.	.	PUNCT
globalce-210	253	1	springer	springer	NOUN
globalce-210	253	2	nature	nature	NOUN
globalce-210	253	3	:	:	PUNCT
globalce-210	254	1	berlin	berlin	PROPN
globalce-210	254	2	,	,	PUNCT
globalce-210	254	3	germany	germany	PROPN
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globalce-210	254	6	;	;	PUNCT
globalce-210	254	7	pp	pp	X
globalce-210	254	8	.	.	PUNCT
globalce-210	255	1	67–115	67–115	NOUN
globalce-210	255	2	.	.	PUNCT
globalce-210	256	1	https://	https://	PROPN
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globalce-210	256	3	.	.	PROPN
globalce-210	256	4	14	14	NUM
globalce-210	256	5	.	.	PUNCT
globalce-210	257	1	importance	importance	NOUN
globalce-210	257	2	of	of	ADP
globalce-210	257	3	compliance	compliance	NOUN
globalce-210	257	4	with	with	ADP
globalce-210	257	5	regulations	regulation	NOUN
globalce-210	257	6	in	in	ADP
globalce-210	257	7	the	the	DET
globalce-210	257	8	pharmaceutical	pharmaceutical	ADJ
globalce-210	257	9	industry	industry	NOUN
globalce-210	257	10	.	.	PUNCT
globalce-210	258	1	available	available	ADJ
globalce-210	258	2	online	online	ADV
globalce-210	258	3	:	:	PUNCT
globalce-210	258	4	https://	https://	PROPN
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globalce-210	258	6	.	.	PROPN
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globalce-210	258	8	.	.	PUNCT
globalce-210	259	1	eu	eu	PROPN
globalce-210	259	2	reach	reach	VERB
globalce-210	259	3	political	political	ADJ
globalce-210	259	4	agreement	agreement	NOUN
globalce-210	259	5	on	on	ADP
globalce-210	259	6	ai	ai	PROPN
globalce-210	259	7	act	act	NOUN
globalce-210	259	8	–	–	PUNCT
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globalce-210	259	10	areas	area	NOUN
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globalce-210	259	12	impact	impact	NOUN
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globalce-210	259	14	life	life	NOUN
globalce-210	259	15	sciences	science	NOUN
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globalce-210	259	17	.	.	PUNCT
globalce-210	260	1	available	available	ADJ
globalce-210	260	2	online	online	ADV
globalce-210	260	3	:	:	PUNCT
globalce-210	261	1	https://	https://	PROPN
globalce-210	261	2	www.sidley.com/en/insights/newsupdates/2023/12/	www.sidley.com/en/insights/newsupdates/2023/12/	X
globalce-210	262	1	eu	eu	ADJ
globalce-210	262	2	-	-	ADJ
globalce-210	262	3	reach	reach	VERB
globalce-210	262	4	-	-	PUNCT
globalce-210	262	5	political	political	ADJ
globalce-210	262	6	-	-	PUNCT
globalce-210	262	7	agreement	agreement	NOUN
globalce-210	262	8	-	-	PUNCT
globalce-210	262	9	on	on	ADP
globalce-210	262	10	-	-	PUNCT
globalce-210	262	11	ai	ai	NOUN
globalce-210	262	12	-	-	PUNCT
globalce-210	262	13	act	act	NOUN
globalce-210	262	14	.	.	PUNCT
globalce-210	263	1	16	16	NUM
globalce-210	263	2	.	.	PUNCT
globalce-210	264	1	european	european	PROPN
globalce-210	264	2	medicines	medicine	NOUN
globalce-210	264	3	agency	agency	NOUN
globalce-210	264	4	.	.	PUNCT
globalce-210	265	1	medical	medical	ADJ
globalce-210	265	2	devices	device	NOUN
globalce-210	265	3	.	.	PUNCT
globalce-210	266	1	available	available	ADJ
globalce-210	266	2	online	online	ADV
globalce-210	266	3	:	:	PUNCT
globalce-210	266	4	https://www.ema.europa.eu/en/	https://www.ema.europa.eu/en/	NOUN
globalce-210	266	5	human	human	ADJ
globalce-210	266	6	-	-	PUNCT
globalce-210	266	7	regulatory	regulatory	ADJ
globalce-210	266	8	-	-	PUNCT
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globalce-210	266	10	/	/	SYM
globalce-210	266	11	medical	medical	ADJ
globalce-210	266	12	-	-	PUNCT
globalce-210	266	13	devices	device	NOUN
globalce-210	266	14	.	.	PUNCT
globalce-210	267	1	17	17	NUM
globalce-210	267	2	.	.	PUNCT
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globalce-210	267	4	.	.	PUNCT
globalce-210	268	1	eu	eu	PROPN
globalce-210	268	2	ema	ema	PROPN
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globalce-210	268	4	risk	risk	NOUN
globalce-210	268	5	-	-	PUNCT
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globalce-210	268	7	approach	approach	NOUN
globalce-210	268	8	to	to	AUX
globalce-210	268	9	ai	ai	VERB
globalce-210	268	10	in	in	ADP
globalce-210	268	11	pharma	pharma	PROPN
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globalce-210	268	13	.	.	PUNCT
globalce-210	269	1	available	available	ADJ
globalce-210	269	2	online	online	ADV
globalce-210	269	3	:	:	PUNCT
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globalce-210	269	5	.	.	PUNCT
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globalce-210	269	7	-	-	PUNCT
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globalce-210	269	9	-	-	PUNCT
globalce-210	269	10	412d	412d	PROPN
globalce-210	269	11	-	-	PUNCT
globalce-210	269	12	b05d-744a5f116c27	b05d-744a5f116c27	PROPN
globalce-210	269	13	.	.	PUNCT
globalce-210	270	1	https://www.scilife.io/blog/artificial-intelligence-regulations	https://www.scilife.io/blog/artificial-intelligence-regulation	NOUN
globalce-210	270	2	https://www.scilife.io/blog/artificial-intelligence-regulations	https://www.scilife.io/blog/artificial-intelligence-regulation	NOUN
globalce-210	270	3	https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-software-medical-device	https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-software-medical-device	VERB
globalce-210	270	4	https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-software-medical-device	https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-software-medical-device	NOUN
globalce-210	270	5	https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-software-medical-device	https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-software-medical-device	NOUN
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globalce-210	271	1	https://www.pda.org/pda-letter-portal/home/full-article/a-comprehensive-review-of-regulatory-intelligence-exploring-tools-and-program-maturities	https://www.pda.org/pda-letter-portal/home/full-article/a-comprehensive-review-of-regulatory-intelligence-exploring-tools-and-program-maturitie	NOUN
globalce-210	271	2	https://www.pda.org/pda-letter-portal/home/full-article/a-comprehensive-review-of-regulatory-intelligence-exploring-tools-and-program-maturities	https://www.pda.org/pda-letter-portal/home/full-article/a-comprehensive-review-of-regulatory-intelligence-exploring-tools-and-program-maturitie	NOUN
globalce-210	271	3	https://www.pda.org/pda-letter-portal/home/full-article/a-comprehensive-review-of-regulatory-intelligence-exploring-tools-and-program-maturities	https://www.pda.org/pda-letter-portal/home/full-article/a-comprehensive-review-of-regulatory-intelligence-exploring-tools-and-program-maturitie	NOUN
globalce-210	271	4	https://www.pda.org/pda-letter-portal/home/full-article/a-comprehensive-review-of-regulatory-intelligence-exploring-tools-and-program-maturities	https://www.pda.org/pda-letter-portal/home/full-article/a-comprehensive-review-of-regulatory-intelligence-exploring-tools-and-program-maturitie	NOUN
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globalce-210	271	12	.	.	PUNCT
globalce-210	272	1	https://www.europarl.europa.eu/topics/en/article/20230601sto93804/eu-ai-act-first-regulation-on-artificial-intelligence	https://www.europarl.europa.eu/topics/en/article/20230601sto93804/eu-ai-act-first-regulation-on-artificial-intelligence	NOUN
globalce-210	272	2	https://www.europarl.europa.eu/topics/en/article/20230601sto93804/eu-ai-act-first-regulation-on-artificial-intelligence	https://www.europarl.europa.eu/topics/en/article/20230601sto93804/eu-ai-act-first-regulation-on-artificial-intelligence	PROPN
globalce-210	272	3	https://www.europarl.europa.eu/topics/en/article/20230601sto93804/eu-ai-act-first-regulation-on-artificial-intelligence	https://www.europarl.europa.eu/topics/en/article/20230601sto93804/eu-ai-act-first-regulation-on-artificial-intelligence	PROPN
globalce-210	272	4	https://www.ema.europa.eu/en/news/artificial-intelligence-workplan-guide-use-ai-medicines-regulation	https://www.ema.europa.eu/en/news/artificial-intelligence-workplan-guide-use-ai-medicines-regulation	PROPN
globalce-210	272	5	https://www.ema.europa.eu/en/news/artificial-intelligence-workplan-guide-use-ai-medicines-regulation	https://www.ema.europa.eu/en/news/artificial-intelligence-workplan-guide-use-ai-medicines-regulation	PROPN
globalce-210	272	6	https://www.ema.europa.eu/en/news/artificial-intelligence-workplan-guide-use-ai-medicines-regulation	https://www.ema.europa.eu/en/news/artificial-intelligence-workplan-guide-use-ai-medicines-regulation	NOUN
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globalce-210	272	13	https://www.sidley.com/en/insights/newsupdates/2023/12/eu-reach-political-agreement-on-ai-act	https://www.sidley.com/en/insights/newsupdates/2023/12/eu-reach-political-agreement-on-ai-act	ADJ
globalce-210	272	14	https://www.sidley.com/en/insights/newsupdates/2023/12/eu-reach-political-agreement-on-ai-act	https://www.sidley.com/en/insights/newsupdates/2023/12/eu-reach-political-agreement-on-ai-act	ADJ
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globalce-210	272	16	https://www.ema.europa.eu/en/human-regulatory-overview/medical-devices	https://www.ema.europa.eu/en/human-regulatory-overview/medical-device	NOUN
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globalce-210	272	27	:	:	SYM
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globalce-210	272	46	medical	medical	ADJ
globalce-210	272	47	devices	device	NOUN
globalce-210	272	48	:	:	PUNCT
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globalce-210	275	2	online	online	ADV
globalce-210	275	3	:	:	PUNCT
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globalce-210	275	5	reflection	reflection	NOUN
globalce-210	275	6	-	-	PUNCT
globalce-210	275	7	paper	paper	NOUN
globalce-210	275	8	-	-	PUNCT
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globalce-210	275	10	-	-	PUNCT
globalce-210	275	11	artificial	artificial	ADJ
globalce-210	275	12	-	-	PUNCT
globalce-210	275	13	intelligence	intelligence	NOUN
globalce-210	275	14	-	-	PUNCT
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globalce-210	275	16	-	-	PUNCT
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globalce-210	275	18	.	.	PUNCT
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globalce-210	276	2	.	.	PUNCT
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globalce-210	276	9	.	.	PUNCT
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globalce-210	277	2	paper	paper	NOUN
globalce-210	277	3	on	on	ADP
globalce-210	277	4	the	the	DET
globalce-210	277	5	use	use	NOUN
globalce-210	277	6	of	of	ADP
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globalce-210	277	13	the	the	DET
globalce-210	277	14	medicinal	medicinal	ADJ
globalce-210	277	15	product	product	NOUN
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globalce-210	278	1	available	available	ADJ
globalce-210	278	2	online	online	ADV
globalce-210	278	3	:	:	PUNCT
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globalce-210	279	2	.	.	PUNCT
globalce-210	280	1	ema.europa.eu/en/documents/scientific-guideline/	ema.europa.eu/en/documents/scientific-guideline/	PROPN
globalce-210	280	2	reflection	reflection	NOUN
globalce-210	280	3	-	-	PUNCT
globalce-210	280	4	paper	paper	NOUN
globalce-210	280	5	-	-	PUNCT
globalce-210	280	6	use	use	NOUN
globalce-210	280	7	-	-	PUNCT
globalce-210	280	8	artificial	artificial	ADJ
globalce-210	280	9	-	-	PUNCT
globalce-210	280	10	intelligence	intelligence	NOUN
globalce-210	280	11	-	-	PUNCT
globalce-210	280	12	ai	ai	NOUN
globalce-210	280	13	-	-	PUNCT
globalce-210	280	14	medicinalproduct	medicinalproduct	NOUN
globalce-210	280	15	-	-	PUNCT
globalce-210	280	16	lifecycle_en.pdf	lifecycle_en.pdf	NOUN
globalce-210	280	17	.	.	PUNCT
globalce-210	281	1	20	20	NUM
globalce-210	281	2	.	.	PUNCT
globalce-210	282	1	benjamens	benjamen	NOUN
globalce-210	282	2	,	,	PUNCT
globalce-210	282	3	s.	s.	PROPN
globalce-210	282	4	,	,	PUNCT
globalce-210	282	5	dhunnoo	dhunnoo	PROPN
globalce-210	282	6	,	,	PUNCT
globalce-210	282	7	p.	p.	PROPN
globalce-210	282	8	,	,	PUNCT
globalce-210	282	9	meskó	meskó	PROPN
globalce-210	282	10	,	,	PUNCT
globalce-210	282	11	b.	b.	PROPN
globalce-210	283	1	the	the	DET
globalce-210	283	2	state	state	NOUN
globalce-210	283	3	of	of	ADP
globalce-210	283	4	artificial	artificial	ADJ
globalce-210	283	5	intelligence	intelligence	NOUN
globalce-210	283	6	-	-	PUNCT
globalce-210	283	7	based	base	VERB
globalce-210	283	8	fda	fda	PROPN
globalce-210	283	9	-	-	PUNCT
globalce-210	283	10	approved	approve	VERB
globalce-210	283	11	medical	medical	ADJ
globalce-210	283	12	devices	device	NOUN
globalce-210	283	13	and	and	CCONJ
globalce-210	283	14	algorithms	algorithm	NOUN
globalce-210	283	15	:	:	PUNCT
globalce-210	283	16	an	an	DET
globalce-210	283	17	online	online	ADJ
globalce-210	283	18	database	database	NOUN
globalce-210	283	19	.	.	PUNCT
globalce-210	284	1	npj	npj	NOUN
globalce-210	284	2	digit	digit	NOUN
globalce-210	284	3	med	med	PROPN
globalce-210	284	4	.	.	PUNCT
globalce-210	285	1	2020;3:118	2020;3:118	NUM
globalce-210	285	2	.	.	PUNCT
globalce-210	286	1	https://doi.org/10.1038/	https://doi.org/10.1038/	PROPN
globalce-210	286	2	s41746	s41746	PROPN
globalce-210	286	3	-	-	PUNCT
globalce-210	286	4	020	020	NUM
globalce-210	286	5	-	-	PUNCT
globalce-210	286	6	00324	00324	NUM
globalce-210	286	7	-	-	SYM
globalce-210	286	8	0	0	NUM
globalce-210	286	9	.	.	NUM
globalce-210	286	10	21	21	NUM
globalce-210	286	11	.	.	PUNCT
globalce-210	287	1	joshi	joshi	PROPN
globalce-210	287	2	,	,	PUNCT
globalce-210	287	3	g.	g.	PROPN
globalce-210	287	4	,	,	PUNCT
globalce-210	287	5	jain	jain	PROPN
globalce-210	287	6	,	,	PUNCT
globalce-210	287	7	a.	a.	PROPN
globalce-210	287	8	,	,	PUNCT
globalce-210	287	9	araveeti	araveeti	PROPN
globalce-210	287	10	,	,	PUNCT
globalce-210	287	11	s.r	s.r	PROPN
globalce-210	287	12	.	.	PROPN
globalce-210	287	13	,	,	PUNCT
globalce-210	287	14	et	et	PROPN
globalce-210	287	15	al	al	PROPN
globalce-210	287	16	.	.	PUNCT
globalce-210	287	17	fda	fda	PROPN
globalce-210	287	18	-	-	PUNCT
globalce-210	287	19	approved	approve	VERB
globalce-210	287	20	artificial	artificial	ADJ
globalce-210	287	21	intelligence	intelligence	NOUN
globalce-210	287	22	and	and	CCONJ
globalce-210	287	23	machine	machine	NOUN
globalce-210	287	24	learning	learning	NOUN
globalce-210	287	25	(	(	PUNCT
globalce-210	287	26	ai	ai	PROPN
globalce-210	287	27	/	/	SYM
globalce-210	287	28	ml)enabled	ml)enabled	ADJ
globalce-210	287	29	medical	medical	ADJ
globalce-210	287	30	devices	device	NOUN
globalce-210	287	31	:	:	PUNCT
globalce-210	287	32	an	an	DET
globalce-210	287	33	updated	update	VERB
globalce-210	287	34	landscape	landscape	NOUN
globalce-210	287	35	.	.	PUNCT
globalce-210	288	1	electron	electron	NOUN
globalce-210	288	2	.	.	PUNCT
globalce-210	289	1	2024;13(3):498	2024;13(3):498	NUM
globalce-210	289	2	.	.	PUNCT
globalce-210	290	1	https://doi.org/10.3390/	https://doi.org/10.3390/	PROPN
globalce-210	290	2	electronics13030498	electronics13030498	PROPN
globalce-210	290	3	.	.	PUNCT
globalce-210	291	1	22	22	NUM
globalce-210	291	2	.	.	PUNCT
globalce-210	292	1	food	food	NOUN
globalce-210	292	2	and	and	CCONJ
globalce-210	292	3	drug	drug	PROPN
globalce-210	292	4	administration	administration	PROPN
globalce-210	292	5	(	(	PUNCT
globalce-210	292	6	fda	fda	PROPN
globalce-210	292	7	)	)	PUNCT
globalce-210	292	8	.	.	PUNCT
globalce-210	293	1	proposed	propose	VERB
globalce-210	293	2	regulatory	regulatory	ADJ
globalce-210	293	3	framework	framework	NOUN
globalce-210	293	4	for	for	ADP
globalce-210	293	5	modifications	modification	NOUN
globalce-210	293	6	to	to	ADP
globalce-210	293	7	artificial	artificial	ADJ
globalce-210	293	8	intelligence	intelligence	NOUN
globalce-210	293	9	/	/	SYM
globalce-210	293	10	machine	machine	NOUN
globalce-210	293	11	learning	learning	NOUN
globalce-210	293	12	(	(	PUNCT
globalce-210	293	13	ai	ai	ADJ
globalce-210	293	14	/	/	SYM
globalce-210	293	15	ml)-based	ml)-base	VERB
globalce-210	293	16	software	software	NOUN
globalce-210	293	17	as	as	ADP
globalce-210	293	18	a	a	DET
globalce-210	293	19	medical	medical	ADJ
globalce-210	293	20	device	device	NOUN
globalce-210	293	21	(	(	PUNCT
globalce-210	293	22	samd	samd	NOUN
globalce-210	293	23	)	)	PUNCT
globalce-210	293	24	.	.	PUNCT
globalce-210	294	1	available	available	ADJ
globalce-210	294	2	online	online	ADV
globalce-210	294	3	:	:	PUNCT
globalce-210	294	4	https://	https://	PROPN
globalce-210	294	5	www.fda.gov/files/medical%20devices/published/	www.fda.gov/files/medical%20devices/published/	PROPN
globalce-210	294	6	us	us	PROPN
globalce-210	294	7	-	-	PUNCT
globalce-210	294	8	fda	fda	PROPN
globalce-210	294	9	-	-	PUNCT
globalce-210	294	10	artificial	artificial	ADJ
globalce-210	294	11	-	-	PUNCT
globalce-210	294	12	intelligence	intelligence	NOUN
globalce-210	294	13	-	-	PUNCT
globalce-210	294	14	and	and	CCONJ
globalce-210	294	15	-	-	PUNCT
globalce-210	294	16	machine	machine	NOUN
globalce-210	294	17	-	-	PUNCT
globalce-210	294	18	learningdiscussion	learningdiscussion	NOUN
globalce-210	294	19	-	-	PUNCT
globalce-210	294	20	paper.pdf	paper.pdf	NOUN
globalce-210	294	21	.	.	NOUN
globalce-210	294	22	23	23	NUM
globalce-210	294	23	.	.	PUNCT
globalce-210	295	1	food	food	NOUN
globalce-210	295	2	and	and	CCONJ
globalce-210	295	3	drug	drug	PROPN
globalce-210	295	4	administration	administration	PROPN
globalce-210	295	5	(	(	PUNCT
globalce-210	295	6	fda	fda	PROPN
globalce-210	295	7	)	)	PUNCT
globalce-210	295	8	.	.	PUNCT
globalce-210	296	1	marketing	marketing	NOUN
globalce-210	296	2	submission	submission	NOUN
globalce-210	296	3	recommendations	recommendation	NOUN
globalce-210	296	4	for	for	ADP
globalce-210	296	5	a	a	DET
globalce-210	296	6	predetermined	predetermine	VERB
globalce-210	296	7	change	change	NOUN
globalce-210	296	8	control	control	NOUN
globalce-210	296	9	plan	plan	NOUN
globalce-210	296	10	for	for	ADP
globalce-210	296	11	artificial	artificial	ADJ
globalce-210	296	12	intelligence	intelligence	NOUN
globalce-210	296	13	/	/	SYM
globalce-210	296	14	machine	machine	NOUN
globalce-210	296	15	learning	learning	NOUN
globalce-210	296	16	(	(	PUNCT
globalce-210	296	17	ai	ai	VERB
globalce-210	296	18	/	/	SYM
globalce-210	296	19	ml)-enabled	ml)-enable	VERB
globalce-210	296	20	device	device	NOUN
globalce-210	296	21	software	software	NOUN
globalce-210	296	22	functions	function	NOUN
globalce-210	296	23	.	.	PUNCT
globalce-210	297	1	available	available	ADJ
globalce-210	297	2	online	online	ADV
globalce-210	297	3	:	:	PUNCT
globalce-210	297	4	https://www.fda.gov/regulatory-information/	https://www.fda.gov/regulatory-information/	PROPN
globalce-210	297	5	search	search	NOUN
globalce-210	297	6	-	-	PUNCT
globalce-210	297	7	fda	fda	NOUN
globalce-210	297	8	-	-	PUNCT
globalce-210	297	9	guidance	guidance	NOUN
globalce-210	297	10	-	-	PUNCT
globalce-210	297	11	documents	document	NOUN
globalce-210	297	12	/	/	SYM
globalce-210	297	13	marketing	marketing	NOUN
globalce-210	297	14	-	-	PUNCT
globalce-210	297	15	submissionrecommendations	submissionrecommendation	NOUN
globalce-210	297	16	-	-	PUNCT
globalce-210	297	17	predetermined	predetermine	VERB
globalce-210	297	18	-	-	PUNCT
globalce-210	297	19	change	change	NOUN
globalce-210	297	20	-	-	PUNCT
globalce-210	297	21	controlplan	controlplan	ADJ
globalce-210	297	22	-	-	PUNCT
globalce-210	297	23	artificial	artificial	ADJ
globalce-210	297	24	.	.	PUNCT
globalce-210	298	1	24	24	NUM
globalce-210	298	2	.	.	PUNCT
globalce-210	298	3	food	food	NOUN
globalce-210	298	4	and	and	CCONJ
globalce-210	298	5	drug	drug	PROPN
globalce-210	298	6	administration	administration	PROPN
globalce-210	298	7	(	(	PUNCT
globalce-210	298	8	fda	fda	PROPN
globalce-210	298	9	)	)	PUNCT
globalce-210	298	10	.	.	PUNCT
globalce-210	299	1	fda	fda	PROPN
globalce-210	299	2	releases	release	VERB
globalce-210	299	3	artificial	artificial	ADJ
globalce-210	299	4	intelligence	intelligence	NOUN
globalce-210	299	5	/	/	SYM
globalce-210	299	6	machine	machine	NOUN
globalce-210	299	7	learning	learn	VERB
globalce-210	299	8	action	action	NOUN
globalce-210	299	9	plan	plan	NOUN
globalce-210	299	10	.	.	PUNCT
globalce-210	300	1	available	available	ADJ
globalce-210	300	2	online	online	ADV
globalce-210	300	3	:	:	PUNCT
globalce-210	300	4	https://www.fda.gov/news-events/	https://www.fda.gov/news-events/	PROPN
globalce-210	300	5	press	press	NOUN
globalce-210	300	6	-	-	PUNCT
globalce-210	300	7	announcements	announcement	NOUN
globalce-210	300	8	/	/	SYM
globalce-210	300	9	fda	fda	PROPN
globalce-210	300	10	-	-	PUNCT
globalce-210	300	11	releases	release	NOUN
globalce-210	300	12	-	-	PUNCT
globalce-210	300	13	artificial	artificial	ADJ
globalce-210	300	14	-	-	PUNCT
globalce-210	300	15	intelligencemachine	intelligencemachine	NOUN
globalce-210	300	16	-	-	PUNCT
globalce-210	300	17	learning	learning	NOUN
globalce-210	300	18	-	-	PUNCT
globalce-210	300	19	action	action	NOUN
globalce-210	300	20	-	-	PUNCT
globalce-210	300	21	plan	plan	NOUN
globalce-210	300	22	.	.	PUNCT
globalce-210	301	1	25	25	NUM
globalce-210	301	2	.	.	PUNCT
globalce-210	301	3	food	food	NOUN
globalce-210	301	4	and	and	CCONJ
globalce-210	301	5	drug	drug	PROPN
globalce-210	301	6	administration	administration	PROPN
globalce-210	301	7	(	(	PUNCT
globalce-210	301	8	fda	fda	PROPN
globalce-210	301	9	)	)	PUNCT
globalce-210	301	10	.	.	PUNCT
globalce-210	302	1	fda	fda	PROPN
globalce-210	302	2	action	action	NOUN
globalce-210	302	3	plan	plan	NOUN
globalce-210	302	4	for	for	ADP
globalce-210	302	5	ai	ai	VERB
globalce-210	302	6	/	/	SYM
globalce-210	302	7	ml	ml	NOUN
globalce-210	302	8	in	in	ADP
globalce-210	302	9	samd	samd	NOUN
globalce-210	302	10	(	(	PUNCT
globalce-210	302	11	software	software	NOUN
globalce-210	302	12	as	as	ADP
globalce-210	302	13	a	a	DET
globalce-210	302	14	medical	medical	ADJ
globalce-210	302	15	device	device	NOUN
globalce-210	302	16	)	)	PUNCT
globalce-210	302	17	.	.	PUNCT
globalce-210	303	1	available	available	ADJ
globalce-210	303	2	online	online	ADV
globalce-210	303	3	:	:	PUNCT
globalce-210	303	4	https://starfishmedical.com/blog/	https://starfishmedical.com/blog/	ADP
globalce-210	303	5	fda	fda	PROPN
globalce-210	303	6	-	-	PUNCT
globalce-210	303	7	action	action	NOUN
globalce-210	303	8	-	-	PUNCT
globalce-210	303	9	plan	plan	NOUN
globalce-210	303	10	-	-	PUNCT
globalce-210	303	11	for	for	ADP
globalce-210	303	12	-	-	PUNCT
globalce-210	303	13	ai	ai	NOUN
globalce-210	303	14	-	-	PUNCT
globalce-210	303	15	ml	ml	NOUN
globalce-210	303	16	-	-	PUNCT
globalce-210	303	17	in	in	ADP
globalce-210	303	18	-	-	PUNCT
globalce-210	303	19	samd	samd	ADJ
globalce-210	303	20	-	-	PUNCT
globalce-210	303	21	software	software	NOUN
globalce-210	303	22	-	-	PUNCT
globalce-210	303	23	as	as	ADP
globalce-210	303	24	-	-	PUNCT
globalce-210	303	25	amedical	amedical	ADJ
globalce-210	303	26	-	-	PUNCT
globalce-210	303	27	device/.	device/.	NOUN
globalce-210	303	28	26	26	NUM
globalce-210	303	29	.	.	PUNCT
globalce-210	304	1	akin	akin	VERB
globalce-210	304	2	.	.	PUNCT
globalce-210	305	1	fda	fda	PROPN
globalce-210	305	2	releases	release	VERB
globalce-210	305	3	action	action	NOUN
globalce-210	305	4	plan	plan	NOUN
globalce-210	305	5	for	for	ADP
globalce-210	305	6	artificial	artificial	ADJ
globalce-210	305	7	intelligence/	intelligence/	NUM
globalce-210	305	8	machine	machine	NOUN
globalce-210	305	9	learning	learning	NOUN
globalce-210	305	10	-	-	PUNCT
globalce-210	305	11	enabled	enable	VERB
globalce-210	305	12	software	software	NOUN
globalce-210	305	13	as	as	ADP
globalce-210	305	14	a	a	DET
globalce-210	305	15	medical	medical	ADJ
globalce-210	305	16	device	device	NOUN
globalce-210	305	17	.	.	PUNCT
globalce-210	306	1	available	available	ADJ
globalce-210	306	2	online	online	ADV
globalce-210	306	3	:	:	PUNCT
globalce-210	306	4	https://www.akingump.com/en/insights/	https://www.akingump.com/en/insights/	NOUN
globalce-210	306	5	alerts	alert	NOUN
globalce-210	306	6	/	/	SYM
globalce-210	306	7	fda	fda	PROPN
globalce-210	306	8	-	-	PUNCT
globalce-210	306	9	releases	release	NOUN
globalce-210	306	10	-	-	PUNCT
globalce-210	306	11	action	action	NOUN
globalce-210	306	12	-	-	PUNCT
globalce-210	306	13	plan	plan	NOUN
globalce-210	306	14	-	-	PUNCT
globalce-210	306	15	for	for	ADP
globalce-210	306	16	-	-	PUNCT
globalce-210	306	17	artificial	artificial	ADJ
globalce-210	306	18	-	-	PUNCT
globalce-210	306	19	intelligencemachine	intelligencemachine	NOUN
globalce-210	306	20	-	-	PUNCT
globalce-210	306	21	learning	learning	NOUN
globalce-210	306	22	-	-	PUNCT
globalce-210	306	23	enabled	enable	VERB
globalce-210	306	24	-	-	PUNCT
globalce-210	306	25	software	software	NOUN
globalce-210	306	26	-	-	PUNCT
globalce-210	306	27	as	as	ADP
globalce-210	306	28	-	-	PUNCT
globalce-210	306	29	a	a	DET
globalce-210	306	30	-	-	PUNCT
globalce-210	306	31	medical	medical	ADJ
globalce-210	306	32	-	-	PUNCT
globalce-210	306	33	device	device	NOUN
globalce-210	306	34	-	-	PUNCT
globalce-210	306	35	providing	provide	VERB
globalce-210	306	36	-	-	PUNCT
globalce-210	306	37	another	another	DET
globalce-210	306	38	-	-	PUNCT
globalce-210	306	39	iterative	iterative	NOUN
globalce-210	306	40	-	-	PUNCT
globalce-210	306	41	step	step	NOUN
globalce-210	306	42	-	-	PUNCT
globalce-210	306	43	forward	forward	NOUN
globalce-210	306	44	-	-	PUNCT
globalce-210	306	45	on	on	ADP
globalce-210	306	46	-	-	PUNCT
globalce-210	306	47	the	the	DET
globalce-210	306	48	-	-	PUNCT
globalce-210	306	49	long	long	ADJ
globalce-210	306	50	-	-	PUNCT
globalce-210	306	51	road	road	NOUN
globalce-210	306	52	-	-	PUNCT
globalce-210	306	53	ahead	ahead	ADV
globalce-210	306	54	.	.	PUNCT
globalce-210	307	1	27	27	NUM
globalce-210	307	2	.	.	X
globalce-210	308	1	zhu	zhu	PROPN
globalce-210	308	2	,	,	PUNCT
globalce-210	308	3	s.	s.	PROPN
globalce-210	308	4	,	,	PUNCT
globalce-210	308	5	gilbert	gilbert	PROPN
globalce-210	308	6	,	,	PUNCT
globalce-210	308	7	m.	m.	NOUN
globalce-210	308	8	,	,	PUNCT
globalce-210	308	9	chetty	chetty	PROPN
globalce-210	308	10	,	,	PUNCT
globalce-210	308	11	i.	i.	PROPN
globalce-210	308	12	,	,	PUNCT
globalce-210	308	13	et	et	PROPN
globalce-210	308	14	al	al	PROPN
globalce-210	308	15	.	.	PUNCT
globalce-210	309	1	the	the	DET
globalce-210	309	2	2021	2021	NUM
globalce-210	309	3	landscape	landscape	NOUN
globalce-210	309	4	of	of	ADP
globalce-210	309	5	fda	fda	PROPN
globalce-210	309	6	-	-	PUNCT
globalce-210	309	7	approved	approve	VERB
globalce-210	309	8	artificial	artificial	ADJ
globalce-210	309	9	intelligence	intelligence	NOUN
globalce-210	309	10	/	/	SYM
globalce-210	309	11	machine	machine	NOUN
globalce-210	309	12	learning	learning	NOUN
globalce-210	309	13	-	-	PUNCT
globalce-210	309	14	enabled	enable	VERB
globalce-210	309	15	medical	medical	ADJ
globalce-210	309	16	devices	device	NOUN
globalce-210	309	17	:	:	PUNCT
globalce-210	309	18	an	an	DET
globalce-210	309	19	analysis	analysis	NOUN
globalce-210	309	20	of	of	ADP
globalce-210	309	21	the	the	DET
globalce-210	309	22	characteristics	characteristic	NOUN
globalce-210	309	23	and	and	CCONJ
globalce-210	309	24	intended	intend	VERB
globalce-210	309	25	use	use	NOUN
globalce-210	309	26	.	.	PUNCT
globalce-210	310	1	int	int	PROPN
globalce-210	310	2	j	j	PROPN
globalce-210	310	3	med	med	ADJ
globalce-210	310	4	inform	inform	NOUN
globalce-210	310	5	.	.	PUNCT
globalce-210	311	1	2022;165:104828	2022;165:104828	X
globalce-210	311	2	.	.	PUNCT
globalce-210	312	1	https://doi.org/10.1016/j	https://doi.org/10.1016/j	NOUN
globalce-210	312	2	.	.	PUNCT
globalce-210	313	1	ijmedinf.2022.104828	ijmedinf.2022.104828	NOUN
globalce-210	313	2	.	.	PUNCT
globalce-210	314	1	28	28	NUM
globalce-210	314	2	.	.	PUNCT
globalce-210	314	3	food	food	NOUN
globalce-210	314	4	and	and	CCONJ
globalce-210	314	5	drug	drug	PROPN
globalce-210	314	6	administration	administration	PROPN
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globalce-210	315	9	ml)-enabled	ml)-enable	VERB
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globalce-210	318	8	-	-	PUNCT
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globalce-210	318	10	-	-	PUNCT
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globalce-210	318	13	samd/	samd/	NUM
globalce-210	318	14	artificial	artificial	ADJ
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globalce-210	319	2	.	.	PUNCT
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globalce-210	320	1	getting	get	VERB
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globalce-210	320	4	fda	fda	PROPN
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globalce-210	320	17	machine	machine	NOUN
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globalce-210	320	19	(	(	PUNCT
globalce-210	320	20	ai	ai	VERB
globalce-210	320	21	/	/	SYM
globalce-210	320	22	ml	ml	NOUN
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globalce-210	320	25	.	.	PUNCT
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globalce-210	321	5	.	.	PUNCT
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globalce-210	321	7	/	/	SYM
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globalce-210	321	9	/	/	SYM
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globalce-210	321	13	/	/	SYM
globalce-210	321	14	getting	getting	NOUN
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globalce-210	321	17	-	-	PUNCT
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globalce-210	321	19	-	-	PUNCT
globalce-210	321	20	draft	draft	NOUN
globalce-210	321	21	-	-	PUNCT
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globalce-210	321	23	-	-	PUNCT
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globalce-210	321	27	-	-	PUNCT
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globalce-210	321	31	-	-	PUNCT
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globalce-210	321	33	-	-	PUNCT
globalce-210	321	34	ai	ai	NOUN
globalce-210	321	35	-	-	PUNCT
globalce-210	321	36	ml	ml	NOUN
globalce-210	321	37	-	-	PUNCT
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globalce-210	321	39	.	.	PUNCT
globalce-210	322	1	30	30	NUM
globalce-210	322	2	.	.	PUNCT
globalce-210	323	1	lecun	lecun	ADJ
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globalce-210	323	4	,	,	PUNCT
globalce-210	323	5	bengio	bengio	PROPN
globalce-210	323	6	,	,	PUNCT
globalce-210	323	7	y.	y.	PROPN
globalce-210	323	8	,	,	PUNCT
globalce-210	323	9	hinton	hinton	PROPN
globalce-210	323	10	,	,	PUNCT
globalce-210	323	11	g.	g.	PROPN
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globalce-210	323	14	.	.	PUNCT
globalce-210	324	1	nature	nature	NOUN
globalce-210	324	2	.	.	PUNCT
globalce-210	325	1	2015;521:436–444	2015;521:436–444	X
globalce-210	325	2	.	.	PUNCT
globalce-210	326	1	https://doi.org/10.1038/	https://doi.org/10.1038/	NOUN
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globalce-210	326	3	.	.	PUNCT
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globalce-210	327	2	.	.	PUNCT
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globalce-210	328	2	,	,	PUNCT
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globalce-210	329	1	the	the	DET
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globalce-210	329	9	artificial	artificial	ADJ
globalce-210	329	10	intelligence	intelligence	NOUN
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globalce-210	329	20	.	.	PUNCT
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globalce-210	331	7	-	-	PUNCT
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globalce-210	331	11	.	.	PUNCT
globalce-210	332	1	https://www.ema.europa.eu/en/news/reflection-paper-use-artificial-intelligence-lifecycle-medicines	https://www.ema.europa.eu/en/news/reflection-paper-use-artificial-intelligence-lifecycle-medicine	NOUN
globalce-210	332	2	https://www.ema.europa.eu/en/news/reflection-paper-use-artificial-intelligence-lifecycle-medicines	https://www.ema.europa.eu/en/news/reflection-paper-use-artificial-intelligence-lifecycle-medicines	PROPN
globalce-210	332	3	https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-use-artificial-intelligence-ai-medicinal-product-lifecycle_en.pdf	https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-use-artificial-intelligence-ai-medicinal-product-lifecycle_en.pdf	PROPN
globalce-210	332	4	https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-use-artificial-intelligence-ai-medicinal-product-lifecycle_en.pdf	https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-use-artificial-intelligence-ai-medicinal-product-lifecycle_en.pdf	PROPN
globalce-210	332	5	https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-use-artificial-intelligence-ai-medicinal-product-lifecycle_en.pdf	https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-use-artificial-intelligence-ai-medicinal-product-lifecycle_en.pdf	PROPN
globalce-210	332	6	https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-use-artificial-intelligence-ai-medicinal-product-lifecycle_en.pdf	https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-use-artificial-intelligence-ai-medicinal-product-lifecycle_en.pdf	PROPN
globalce-210	332	7	https://doi.org/10.1038/s41746-020-00324-0	https://doi.org/10.1038/s41746-020-00324-0	NUM
globalce-210	332	8	https://doi.org/10.1038/s41746-020-00324-0	https://doi.org/10.1038/s41746-020-00324-0	NUM
globalce-210	332	9	https://doi.org/10.3390/electronics13030498	https://doi.org/10.3390/electronics13030498	PROPN
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globalce-210	332	11	https://www.fda.gov/files/medical%20devices/published/us-fda-artificial-intelligence-and-machine-learning-discussion-paper.pdf	https://www.fda.gov/files/medical%20devices/published/us-fda-artificial-intelligence-and-machine-learning-discussion-paper.pdf	NOUN
globalce-210	332	12	https://www.fda.gov/files/medical%20devices/published/us-fda-artificial-intelligence-and-machine-learning-discussion-paper.pdf	https://www.fda.gov/files/medical%20devices/published/us-fda-artificial-intelligence-and-machine-learning-discussion-paper.pdf	PROPN
globalce-210	332	13	https://www.fda.gov/files/medical%20devices/published/us-fda-artificial-intelligence-and-machine-learning-discussion-paper.pdf	https://www.fda.gov/files/medical%20devices/published/us-fda-artificial-intelligence-and-machine-learning-discussion-paper.pdf	PROPN
globalce-210	332	14	https://www.fda.gov/files/medical%20devices/published/us-fda-artificial-intelligence-and-machine-learning-discussion-paper.pdf	https://www.fda.gov/files/medical%20devices/published/us-fda-artificial-intelligence-and-machine-learning-discussion-paper.pdf	PROPN
globalce-210	332	15	https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial	https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial	ADJ
globalce-210	332	16	https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial	https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial	ADJ
globalce-210	332	17	https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial	https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial	ADJ
globalce-210	332	18	https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial	https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial	ADJ
globalce-210	332	19	https://www.fda.gov/news-events/press-announcements/fda-releases-artificial-intelligencemachine-learning-action-plan	https://www.fda.gov/news-events/press-announcements/fda-releases-artificial-intelligencemachine-learning-action-plan	NOUN
globalce-210	332	20	https://www.fda.gov/news-events/press-announcements/fda-releases-artificial-intelligencemachine-learning-action-plan	https://www.fda.gov/news-events/press-announcements/fda-releases-artificial-intelligencemachine-learning-action-plan	NOUN
globalce-210	332	21	https://www.fda.gov/news-events/press-announcements/fda-releases-artificial-intelligencemachine-learning-action-plan	https://www.fda.gov/news-events/press-announcements/fda-releases-artificial-intelligencemachine-learning-action-plan	PROPN
globalce-210	332	22	https://starfishmedical.com/blog/fda-action-plan-for-ai-ml-in-samd-software-as-a-medical-device/	https://starfishmedical.com/blog/fda-action-plan-for-ai-ml-in-samd-software-as-a-medical-device/	PROPN
globalce-210	332	23	https://starfishmedical.com/blog/fda-action-plan-for-ai-ml-in-samd-software-as-a-medical-device/	https://starfishmedical.com/blog/fda-action-plan-for-ai-ml-in-samd-software-as-a-medical-device/	PROPN
globalce-210	332	24	https://starfishmedical.com/blog/fda-action-plan-for-ai-ml-in-samd-software-as-a-medical-device/	https://starfishmedical.com/blog/fda-action-plan-for-ai-ml-in-samd-software-as-a-medical-device/	PROPN
globalce-210	332	25	https://www.akingump.com/en/insights/alerts/fda-releases-action-plan-for-artificial-intelligencemachine-learning-enabled-software-as-a-medical-device-providing-another-iterative-step-forward-on-the-long-road-ahead	https://www.akingump.com/en/insights/alerts/fda-releases-action-plan-for-artificial-intelligencemachine-learning-enabled-software-as-a-medical-device-providing-another-iterative-step-forward-on-the-long-road-ahead	VERB
globalce-210	332	26	https://www.akingump.com/en/insights/alerts/fda-releases-action-plan-for-artificial-intelligencemachine-learning-enabled-software-as-a-medical-device-providing-another-iterative-step-forward-on-the-long-road-ahead	https://www.akingump.com/en/insights/alerts/fda-releases-action-plan-for-artificial-intelligencemachine-learning-enabled-software-as-a-medical-device-providing-another-iterative-step-forward-on-the-long-road-ahead	PROPN
globalce-210	332	27	https://www.akingump.com/en/insights/alerts/fda-releases-action-plan-for-artificial-intelligencemachine-learning-enabled-software-as-a-medical-device-providing-another-iterative-step-forward-on-the-long-road-ahead	https://www.akingump.com/en/insights/alerts/fda-releases-action-plan-for-artificial-intelligencemachine-learning-enabled-software-as-a-medical-device-providing-another-iterative-step-forward-on-the-long-road-ahead	PROPN
globalce-210	332	28	https://www.akingump.com/en/insights/alerts/fda-releases-action-plan-for-artificial-intelligencemachine-learning-enabled-software-as-a-medical-device-providing-another-iterative-step-forward-on-the-long-road-ahead	https://www.akingump.com/en/insights/alerts/fda-releases-action-plan-for-artificial-intelligencemachine-learning-enabled-software-as-a-medical-device-providing-another-iterative-step-forward-on-the-long-road-ahead	PROPN
globalce-210	332	29	https://doi.org/10.1016/j.ijmedinf.2022.104828	https://doi.org/10.1016/j.ijmedinf.2022.104828	PROPN
globalce-210	332	30	https://doi.org/10.1016/j.ijmedinf.2022.104828	https://doi.org/10.1016/j.ijmedinf.2022.104828	NOUN
globalce-210	332	31	https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-aiml-enabled-medical-devices	https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-aiml-enabled-medical-device	NOUN
globalce-210	332	32	https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-aiml-enabled-medical-devices	https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-aiml-enabled-medical-device	NOUN
globalce-210	332	33	https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-aiml-enabled-medical-devices	https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-aiml-enabled-medical-device	NOUN
globalce-210	332	34	https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-aiml-enabled-medical-devices	https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-aiml-enabled-medical-device	NOUN
globalce-210	332	35	https://www.ropesgray.com/en/insights/alerts/2023/05/getting-smarter-fda-publishes-draft-guidance-on-predetermined-change-control-plans-for-ai-ml-devices	https://www.ropesgray.com/en/insights/alerts/2023/05/getting-smarter-fda-publishes-draft-guidance-on-predetermined-change-control-plans-for-ai-ml-device	NOUN
globalce-210	332	36	https://www.ropesgray.com/en/insights/alerts/2023/05/getting-smarter-fda-publishes-draft-guidance-on-predetermined-change-control-plans-for-ai-ml-devices	https://www.ropesgray.com/en/insights/alerts/2023/05/getting-smarter-fda-publishes-draft-guidance-on-predetermined-change-control-plans-for-ai-ml-device	NOUN
globalce-210	332	37	https://www.ropesgray.com/en/insights/alerts/2023/05/getting-smarter-fda-publishes-draft-guidance-on-predetermined-change-control-plans-for-ai-ml-devices	https://www.ropesgray.com/en/insights/alerts/2023/05/getting-smarter-fda-publishes-draft-guidance-on-predetermined-change-control-plans-for-ai-ml-devices	PROPN
globalce-210	332	38	https://www.ropesgray.com/en/insights/alerts/2023/05/getting-smarter-fda-publishes-draft-guidance-on-predetermined-change-control-plans-for-ai-ml-devices	https://www.ropesgray.com/en/insights/alerts/2023/05/getting-smarter-fda-publishes-draft-guidance-on-predetermined-change-control-plans-for-ai-ml-devices	PROPN
globalce-210	332	39	https://doi.org/10.1038/nature14539	https://doi.org/10.1038/nature14539	PROPN
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globalce-210	332	76	issue	issue	NOUN
globalce-210	332	77	2	2	NUM
globalce-210	332	78	:	:	SYM
globalce-210	332	79	2025	2025	NUM
globalce-210	332	80	24	24	NUM
globalce-210	332	81	32	32	NUM
globalce-210	332	82	.	.	PUNCT
globalce-210	333	1	bharadwaj	bharadwaj	PROPN
globalce-210	333	2	,	,	PUNCT
globalce-210	333	3	m.s	m.s	PROPN
globalce-210	333	4	.	.	PROPN
globalce-210	333	5	regulatory	regulatory	ADJ
globalce-210	333	6	insights	insight	NOUN
globalce-210	333	7	in	in	ADP
globalce-210	333	8	digital	digital	ADJ
globalce-210	333	9	health	health	NOUN
globalce-210	333	10	.	.	PUNCT
globalce-210	334	1	in	in	ADP
globalce-210	334	2	multi	multi	ADJ
globalce-210	334	3	-	-	ADJ
globalce-210	334	4	sector	sector	ADJ
globalce-210	334	5	analysis	analysis	NOUN
globalce-210	334	6	of	of	ADP
globalce-210	334	7	the	the	DET
globalce-210	334	8	digital	digital	ADJ
globalce-210	334	9	healthcare	healthcare	PROPN
globalce-210	334	10	industry	industry	NOUN
globalce-210	334	11	,	,	PUNCT
globalce-210	334	12	chatterjee	chatterjee	PROPN
globalce-210	334	13	,	,	PUNCT
globalce-210	334	14	l.	l.	PROPN
globalce-210	334	15	,	,	PUNCT
globalce-210	334	16	gani	gani	PROPN
globalce-210	334	17	,	,	PUNCT
globalce-210	334	18	n.	n.	PROPN
globalce-210	334	19	,	,	PUNCT
globalce-210	334	20	igi	igi	PROPN
globalce-210	334	21	global	global	ADJ
globalce-210	334	22	scientific	scientific	ADJ
globalce-210	334	23	publishing	publishing	NOUN
globalce-210	334	24	:	:	PUNCT
globalce-210	334	25	hershey	hershey	PROPN
globalce-210	334	26	,	,	PUNCT
globalce-210	334	27	pa	pa	PROPN
globalce-210	334	28	;	;	PUNCT
globalce-210	334	29	usa	usa	PROPN
globalce-210	334	30	,	,	PUNCT
globalce-210	334	31	2024	2024	NUM
globalce-210	334	32	;	;	PUNCT
globalce-210	334	33	pp.164–197	pp.164–197	PROPN
globalce-210	334	34	.	.	PROPN
globalce-210	335	1	33	33	NUM
globalce-210	335	2	.	.	PUNCT
globalce-210	336	1	ddreg	ddreg	PROPN
globalce-210	336	2	pharma	pharma	PROPN
globalce-210	336	3	.	.	PUNCT
globalce-210	337	1	regulatory	regulatory	ADJ
globalce-210	337	2	guidelines	guideline	NOUN
globalce-210	337	3	for	for	ADP
globalce-210	337	4	software	software	NOUN
globalce-210	337	5	and	and	CCONJ
globalce-210	337	6	ai	ai	VERB
globalce-210	337	7	medical	medical	ADJ
globalce-210	337	8	devices	device	NOUN
globalce-210	337	9	.	.	PUNCT
globalce-210	338	1	available	available	ADJ
globalce-210	338	2	online	online	ADV
globalce-210	338	3	:	:	PUNCT
globalce-210	338	4	https://resource	https://resource	X
globalce-210	338	5	.	.	PROPN
globalce-210	338	6	ddregpharma.com/blogs/regulatory-guidelines-forsoftware-and-artificial-intelligence-as-a-medical-device/.	ddregpharma.com/blogs/regulatory-guidelines-forsoftware-and-artificial-intelligence-as-a-medical-device/.	PROPN
globalce-210	338	7	34	34	NUM
globalce-210	338	8	.	.	PUNCT
globalce-210	339	1	central	central	ADJ
globalce-210	339	2	drugs	drug	NOUN
globalce-210	339	3	standard	standard	PROPN
globalce-210	339	4	control	control	PROPN
globalce-210	339	5	organization	organization	PROPN
globalce-210	339	6	(	(	PUNCT
globalce-210	339	7	cdsco	cdsco	NOUN
globalce-210	339	8	)	)	PUNCT
globalce-210	339	9	directorate	directorate	ADJ
globalce-210	339	10	general	general	NOUN
globalce-210	339	11	of	of	ADP
globalce-210	339	12	health	health	PROPN
globalce-210	339	13	services	services	PROPN
globalce-210	339	14	ministry	ministry	PROPN
globalce-210	339	15	of	of	ADP
globalce-210	339	16	health	health	PROPN
globalce-210	339	17	and	and	CCONJ
globalce-210	339	18	family	family	NOUN
globalce-210	339	19	welfare	welfare	NOUN
globalce-210	339	20	government	government	NOUN
globalce-210	339	21	of	of	ADP
globalce-210	339	22	india	india	PROPN
globalce-210	339	23	.	.	PUNCT
globalce-210	340	1	available	available	ADJ
globalce-210	340	2	online	online	ADV
globalce-210	340	3	:	:	PUNCT
globalce-210	340	4	https://cdsco.gov.in/opencms/resources/uploadcdscoweb/2018/uploadtenderfile/	https://cdsco.gov.in/opencms/resources/uploadcdscoweb/2018/uploadtenderfile/	PROPN
globalce-210	340	5	corrigendum_to_cdsco_eoi_ssp_01st_dec.pdf	corrigendum_to_cdsco_eoi_ssp_01st_dec.pdf	PROPN
globalce-210	340	6	.	.	PROPN
globalce-210	340	7	35	35	NUM
globalce-210	340	8	.	.	PUNCT
globalce-210	341	1	freyr	freyr	PROPN
globalce-210	341	2	solutions	solution	NOUN
globalce-210	341	3	.	.	PUNCT
globalce-210	342	1	regulation	regulation	NOUN
globalce-210	342	2	of	of	ADP
globalce-210	342	3	software	software	NOUN
globalce-210	342	4	as	as	ADP
globalce-210	342	5	medical	medical	ADJ
globalce-210	342	6	device	device	NOUN
globalce-210	342	7	(	(	PUNCT
globalce-210	342	8	samd	samd	ADJ
globalce-210	342	9	)	)	PUNCT
globalce-210	342	10	in	in	ADP
globalce-210	342	11	india	india	PROPN
globalce-210	342	12	.	.	PUNCT
globalce-210	343	1	available	available	ADJ
globalce-210	343	2	online	online	ADV
globalce-210	343	3	:	:	PUNCT
globalce-210	343	4	https://www.freyrsolutions.com/blog/	https://www.freyrsolutions.com/blog/	PUNCT
globalce-210	343	5	regulation	regulation	NOUN
globalce-210	343	6	-	-	PUNCT
globalce-210	343	7	of	of	ADP
globalce-210	343	8	-	-	PUNCT
globalce-210	343	9	software	software	NOUN
globalce-210	343	10	-	-	PUNCT
globalce-210	343	11	as	as	ADP
globalce-210	343	12	-	-	PUNCT
globalce-210	343	13	medical	medical	ADJ
globalce-210	343	14	-	-	PUNCT
globalce-210	343	15	device	device	NOUN
globalce-210	343	16	-	-	PUNCT
globalce-210	343	17	samd	samd	NOUN
globalce-210	343	18	-	-	PUNCT
globalce-210	343	19	in	in	ADP
globalce-210	343	20	-	-	PUNCT
globalce-210	343	21	india	india	NOUN
globalce-210	343	22	.	.	PUNCT
globalce-210	344	1	36	36	NUM
globalce-210	344	2	.	.	PUNCT
globalce-210	345	1	international	international	ADJ
globalce-210	345	2	medical	medical	ADJ
globalce-210	345	3	device	device	NOUN
globalce-210	345	4	regulators	regulator	NOUN
globalce-210	345	5	forum	forum	NOUN
globalce-210	345	6	(	(	PUNCT
globalce-210	345	7	imdrf	imdrf	PROPN
globalce-210	345	8	)	)	PUNCT
globalce-210	345	9	.	.	PUNCT
globalce-210	346	1	essential	essential	ADJ
globalce-210	346	2	principles	principle	NOUN
globalce-210	346	3	of	of	ADP
globalce-210	346	4	safety	safety	NOUN
globalce-210	346	5	and	and	CCONJ
globalce-210	346	6	performance	performance	NOUN
globalce-210	346	7	of	of	ADP
globalce-210	346	8	medical	medical	ADJ
globalce-210	346	9	devices	device	NOUN
globalce-210	346	10	and	and	CCONJ
globalce-210	346	11	ivd	ivd	PROPN
globalce-210	346	12	medical	medical	ADJ
globalce-210	346	13	devices	device	NOUN
globalce-210	346	14	.	.	PUNCT
globalce-210	347	1	available	available	ADJ
globalce-210	347	2	online	online	ADV
globalce-210	347	3	:	:	PUNCT
globalce-210	347	4	https://	https://	PROPN
globalce-210	347	5	www.imdrf.org/sites/default/files/2024-04/imdrf%20	www.imdrf.org/sites/default/files/2024-04/imdrf%20	PROPN
globalce-210	347	6	grrp%20wg%20n47%20%28edition%202%29.pdf	grrp%20wg%20n47%20%28edition%202%29.pdf	PROPN
globalce-210	347	7	.	.	PUNCT
globalce-210	348	1	37	37	NUM
globalce-210	348	2	.	.	PUNCT
globalce-210	349	1	international	international	ADJ
globalce-210	349	2	medical	medical	ADJ
globalce-210	349	3	device	device	NOUN
globalce-210	349	4	regulators	regulator	NOUN
globalce-210	349	5	forum	forum	NOUN
globalce-210	349	6	(	(	PUNCT
globalce-210	349	7	imdrf	imdrf	PROPN
globalce-210	349	8	)	)	PUNCT
globalce-210	349	9	.	.	PUNCT
globalce-210	350	1	medical	medical	ADJ
globalce-210	350	2	device	device	NOUN
globalce-210	350	3	regulatory	regulatory	ADJ
globalce-210	350	4	review	review	NOUN
globalce-210	350	5	report	report	NOUN
globalce-210	350	6	:	:	PUNCT
globalce-210	350	7	guidance	guidance	NOUN
globalce-210	350	8	regarding	regard	VERB
globalce-210	350	9	information	information	NOUN
globalce-210	350	10	to	to	PART
globalce-210	350	11	be	be	AUX
globalce-210	350	12	included	include	VERB
globalce-210	350	13	.	.	PUNCT
globalce-210	351	1	available	available	ADJ
globalce-210	351	2	online	online	ADV
globalce-210	351	3	:	:	PUNCT
globalce-210	351	4	https://www.imdrf.org/sites/default/	https://www.imdrf.org/sites/default/	ADJ
globalce-210	351	5	files/2024	files/2024	NOUN
globalce-210	351	6	-	-	PUNCT
globalce-210	351	7	04	04	NUM
globalce-210	351	8	/	/	SYM
globalce-210	351	9	imdrf%20grrp%20wg%20n71%20	imdrf%20grrp%20wg%20n71%20	PROPN
globalce-210	351	10	%	%	NOUN
globalce-210	351	11	28edition%202%29_0.pdf	28edition%202%29_0.pdf	NUM
globalce-210	351	12	.	.	PUNCT
globalce-210	352	1	38	38	NUM
globalce-210	352	2	.	.	PUNCT
globalce-210	353	1	international	international	ADJ
globalce-210	353	2	medical	medical	ADJ
globalce-210	353	3	device	device	NOUN
globalce-210	353	4	regulators	regulator	NOUN
globalce-210	353	5	forum	forum	NOUN
globalce-210	353	6	(	(	PUNCT
globalce-210	353	7	imdrf	imdrf	PROPN
globalce-210	353	8	)	)	PUNCT
globalce-210	353	9	.	.	PUNCT
globalce-210	354	1	principles	principle	NOUN
globalce-210	354	2	of	of	ADP
globalce-210	354	3	labeling	labeling	NOUN
globalce-210	354	4	for	for	ADP
globalce-210	354	5	medical	medical	ADJ
globalce-210	354	6	devices	device	NOUN
globalce-210	354	7	and	and	CCONJ
globalce-210	354	8	ivd	ivd	PROPN
globalce-210	354	9	medical	medical	ADJ
globalce-210	354	10	devices	device	NOUN
globalce-210	354	11	.	.	PUNCT
globalce-210	355	1	available	available	ADJ
globalce-210	355	2	online	online	ADV
globalce-210	355	3	:	:	PUNCT
globalce-210	356	1	https://www	https://www	PROPN
globalce-210	356	2	.	.	PUNCT
globalce-210	356	3	imdrf.org/sites/default/files/2024-04/imdrf%20	imdrf.org/sites/default/files/2024-04/imdrf%20	PROPN
globalce-210	357	1	grrp%20wg%20n52%20%28edition%202%29.pdf	grrp%20wg%20n52%20%28edition%202%29.pdf	PROPN
globalce-210	357	2	.	.	PUNCT
globalce-210	358	1	39	39	NUM
globalce-210	358	2	.	.	PUNCT
globalce-210	359	1	rajpurkar	rajpurkar	PROPN
globalce-210	359	2	,	,	PUNCT
globalce-210	359	3	p.	p.	PROPN
globalce-210	359	4	,	,	PUNCT
globalce-210	359	5	chen	chen	PROPN
globalce-210	359	6	,	,	PUNCT
globalce-210	359	7	e.	e.	PROPN
globalce-210	359	8	,	,	PUNCT
globalce-210	359	9	banerjee	banerjee	PROPN
globalce-210	359	10	,	,	PUNCT
globalce-210	359	11	o.	o.	PROPN
globalce-210	359	12	,	,	PUNCT
globalce-210	359	13	et	et	PROPN
globalce-210	359	14	al	al	PROPN
globalce-210	359	15	.	.	PUNCT
globalce-210	359	16	ai	ai	VERB
globalce-210	359	17	in	in	ADP
globalce-210	359	18	health	health	NOUN
globalce-210	359	19	and	and	CCONJ
globalce-210	359	20	medicine	medicine	NOUN
globalce-210	359	21	.	.	PUNCT
globalce-210	360	1	nat	nat	PROPN
globalce-210	360	2	med	me	VERB
globalce-210	360	3	.	.	PUNCT
globalce-210	361	1	2022;28:31–38	2022;28:31–38	NUM
globalce-210	361	2	.	.	PUNCT
globalce-210	362	1	https://doi	https://doi	NOUN
globalce-210	362	2	.	.	PUNCT
globalce-210	363	1	org/10.1038	org/10.1038	PROPN
globalce-210	363	2	/	/	SYM
globalce-210	363	3	s41591	s41591	NOUN
globalce-210	363	4	-	-	PUNCT
globalce-210	363	5	021	021	NUM
globalce-210	363	6	-	-	PUNCT
globalce-210	363	7	01614	01614	NUM
globalce-210	363	8	-	-	PUNCT
globalce-210	363	9	0	0	NUM
globalce-210	363	10	.	.	NUM
globalce-210	363	11	40	40	NUM
globalce-210	363	12	.	.	PUNCT
globalce-210	364	1	comparative	comparative	ADJ
globalce-210	364	2	analysis	analysis	NOUN
globalce-210	364	3	of	of	ADP
globalce-210	364	4	artificial	artificial	ADJ
globalce-210	364	5	intelligence	intelligence	NOUN
globalce-210	364	6	on	on	ADP
globalce-210	364	7	medical	medical	ADJ
globalce-210	364	8	device	device	NOUN
globalce-210	364	9	regulations	regulation	NOUN
globalce-210	364	10	and	and	CCONJ
globalce-210	364	11	legislation	legislation	NOUN
globalce-210	364	12	in	in	ADP
globalce-210	364	13	us	we	PRON
globalce-210	364	14	and	and	CCONJ
globalce-210	364	15	eu	eu	PROPN
globalce-210	364	16	.	.	PROPN
globalce-210	364	17	available	available	ADJ
globalce-210	364	18	online	online	ADV
globalce-210	364	19	:	:	PUNCT
globalce-210	364	20	https://www.theseus.fi/bitstream/	https://www.theseus.fi/bitstream/	PROPN
globalce-210	364	21	handle/10024/506136	handle/10024/506136	NOUN
globalce-210	364	22	/	/	SYM
globalce-210	364	23	nawar_bushra_2021_comparative%20analysis%20of%20artificial%20intelligence%20on%20medical%20device%20regulations%20	nawar_bushra_2021_comparative%20analysis%20of%20artificial%20intelligence%20on%20medical%20device%20regulations%20	NOUN
globalce-210	364	24	and%20legislation%20in%20us%20and%20eu	and%20legislation%20in%20us%20and%20eu	NOUN
globalce-210	364	25	.	.	PUNCT
globalce-210	365	1	pdf?sequence=2	pdf?sequence=2	NOUN
globalce-210	365	2	.	.	PROPN
globalce-210	366	1	41	41	NUM
globalce-210	366	2	.	.	PUNCT
globalce-210	367	1	how	how	SCONJ
globalce-210	367	2	the	the	DET
globalce-210	367	3	challenge	challenge	NOUN
globalce-210	367	4	of	of	ADP
globalce-210	367	5	regulating	regulate	VERB
globalce-210	367	6	ai	ai	VERB
globalce-210	367	7	in	in	ADP
globalce-210	367	8	healthcare	healthcare	NOUN
globalce-210	367	9	is	be	AUX
globalce-210	367	10	escalating	escalate	VERB
globalce-210	367	11	.	.	PUNCT
globalce-210	368	1	available	available	ADJ
globalce-210	368	2	online	online	ADV
globalce-210	368	3	:	:	PUNCT
globalce-210	369	1	https://www.ey.com/en_gl/insights/law/	https://www.ey.com/en_gl/insights/law/	ADP
globalce-210	369	2	how	how	SCONJ
globalce-210	369	3	-	-	PUNCT
globalce-210	369	4	the	the	DET
globalce-210	369	5	-	-	PUNCT
globalce-210	369	6	challenge	challenge	NOUN
globalce-210	369	7	-	-	PUNCT
globalce-210	369	8	of	of	ADP
globalce-210	369	9	-	-	PUNCT
globalce-210	369	10	regulating	regulating	NOUN
globalce-210	369	11	-	-	PUNCT
globalce-210	369	12	ai	ai	NOUN
globalce-210	369	13	-	-	PUNCT
globalce-210	369	14	in	in	ADP
globalce-210	369	15	-	-	PUNCT
globalce-210	369	16	healthcare	healthcare	NOUN
globalce-210	369	17	-	-	PUNCT
globalce-210	369	18	is	be	AUX
globalce-210	369	19	-	-	PUNCT
globalce-210	369	20	escalating	escalate	VERB
globalce-210	369	21	.	.	PUNCT
globalce-210	370	1	42	42	NUM
globalce-210	370	2	.	.	PUNCT
globalce-210	370	3	onitiu	onitiu	PROPN
globalce-210	370	4	,	,	PUNCT
globalce-210	370	5	d.	d.	PROPN
globalce-210	370	6	,	,	PUNCT
globalce-210	370	7	wachter	wachter	NOUN
globalce-210	370	8	,	,	PUNCT
globalce-210	370	9	s.	s.	PROPN
globalce-210	370	10	,	,	PUNCT
globalce-210	370	11	mittelstadt	mittelstadt	NOUN
globalce-210	370	12	,	,	PUNCT
globalce-210	370	13	b.	b.	PROPN
globalce-210	371	1	how	how	SCONJ
globalce-210	371	2	ai	ai	AUX
globalce-210	371	3	challenges	challenge	VERB
globalce-210	371	4	the	the	DET
globalce-210	371	5	medical	medical	ADJ
globalce-210	371	6	device	device	NOUN
globalce-210	371	7	regulation	regulation	NOUN
globalce-210	371	8	:	:	PUNCT
globalce-210	371	9	patient	patient	ADJ
globalce-210	371	10	safety	safety	NOUN
globalce-210	371	11	,	,	PUNCT
globalce-210	371	12	benefits	benefit	NOUN
globalce-210	371	13	,	,	PUNCT
globalce-210	371	14	and	and	CCONJ
globalce-210	371	15	intended	intend	VERB
globalce-210	371	16	uses	use	NOUN
globalce-210	371	17	.	.	PUNCT
globalce-210	372	1	j	j	PROPN
globalce-210	372	2	law	law	PROPN
globalce-210	372	3	biosci	biosci	PROPN
globalce-210	372	4	.	.	PUNCT
globalce-210	373	1	2024;lsae007	2024;lsae007	NUM
globalce-210	373	2	.	.	PUNCT
globalce-210	374	1	https://	https://	PROPN
globalce-210	374	2	doi.org/10.1093/jlb/lsae007	doi.org/10.1093/jlb/lsae007	PROPN
globalce-210	374	3	.	.	PROPN
globalce-210	375	1	43	43	NUM
globalce-210	375	2	.	.	PUNCT
globalce-210	376	1	raji	raji	PROPN
globalce-210	376	2	,	,	PUNCT
globalce-210	376	3	i.d	i.d	PROPN
globalce-210	376	4	.	.	PROPN
globalce-210	376	5	,	,	PUNCT
globalce-210	376	6	kumar	kumar	PROPN
globalce-210	376	7	,	,	PUNCT
globalce-210	376	8	i.e.	i.e.	X
globalce-210	376	9	,	,	PUNCT
globalce-210	376	10	horowitz	horowitz	PROPN
globalce-210	376	11	,	,	PUNCT
globalce-210	376	12	a.	a.	PROPN
globalce-210	376	13	,	,	PUNCT
globalce-210	376	14	et	et	PROPN
globalce-210	376	15	al	al	PROPN
globalce-210	376	16	.	.	PUNCT
globalce-210	377	1	the	the	DET
globalce-210	377	2	fallacy	fallacy	NOUN
globalce-210	377	3	of	of	ADP
globalce-210	377	4	ai	ai	PRON
globalce-210	377	5	functionality	functionality	NOUN
globalce-210	377	6	.	.	PUNCT
globalce-210	378	1	acm	acm	PROPN
globalce-210	378	2	int	int	NOUN
globalce-210	378	3	conf	conf	NOUN
globalce-210	378	4	proc	proc	NOUN
globalce-210	378	5	.	.	PUNCT
globalce-210	379	1	2022:959–972	2022:959–972	PROPN
globalce-210	379	2	(	(	PUNCT
globalce-210	379	3	published	publish	VERB
globalce-210	379	4	online	online	ADJ
globalce-210	379	5	june	june	PROPN
globalce-210	379	6	21	21	NUM
globalce-210	379	7	)	)	PUNCT
globalce-210	379	8	.	.	PUNCT
globalce-210	380	1	https://doi.org/10.1145/3531146.3533158	https://doi.org/10.1145/3531146.3533158	NOUN
globalce-210	380	2	.	.	PUNCT
globalce-210	381	1	44	44	NUM
globalce-210	381	2	.	.	PUNCT
globalce-210	382	1	matheny	matheny	PROPN
globalce-210	382	2	,	,	PUNCT
globalce-210	382	3	m.e	m.e	PROPN
globalce-210	382	4	.	.	PROPN
globalce-210	382	5	,	,	PUNCT
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globalce-210	382	7	,	,	PUNCT
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globalce-210	382	9	,	,	PUNCT
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globalce-210	382	11	israni	israni	NOUN
globalce-210	382	12	,	,	PUNCT
globalce-210	382	13	s.	s.	PROPN
globalce-210	382	14	artificial	artificial	PROPN
globalce-210	382	15	intelligence	intelligence	PROPN
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globalce-210	382	17	health	health	NOUN
globalce-210	382	18	care	care	NOUN
globalce-210	382	19	:	:	PUNCT
globalce-210	382	20	a	a	DET
globalce-210	382	21	report	report	NOUN
globalce-210	382	22	from	from	ADP
globalce-210	382	23	the	the	DET
globalce-210	382	24	national	national	PROPN
globalce-210	382	25	academy	academy	PROPN
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globalce-210	382	28	.	.	PUNCT
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globalce-210	383	2	.	.	PUNCT
globalce-210	384	1	2020;323(6):509–510	2020;323(6):509–510	NUM
globalce-210	384	2	.	.	PUNCT
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globalce-210	385	2	.	.	PROPN
globalce-210	386	1	45	45	NUM
globalce-210	386	2	.	.	PUNCT
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globalce-210	386	4	,	,	PUNCT
globalce-210	386	5	b.	b.	PROPN
globalce-210	386	6	,	,	PUNCT
globalce-210	386	7	fatima	fatima	PROPN
globalce-210	386	8	,	,	PUNCT
globalce-210	386	9	h.	h.	PROPN
globalce-210	386	10	,	,	PUNCT
globalce-210	386	11	qureshi	qureshi	PROPN
globalce-210	386	12	,	,	PUNCT
globalce-210	386	13	a.	a.	PROPN
globalce-210	386	14	,	,	PUNCT
globalce-210	386	15	et	et	PROPN
globalce-210	386	16	al	al	PROPN
globalce-210	386	17	.	.	PUNCT
globalce-210	386	18	drawbacks	drawback	NOUN
globalce-210	386	19	of	of	ADP
globalce-210	386	20	artificial	artificial	ADJ
globalce-210	386	21	intelligence	intelligence	NOUN
globalce-210	386	22	and	and	CCONJ
globalce-210	386	23	their	their	PRON
globalce-210	386	24	potential	potential	ADJ
globalce-210	386	25	solutions	solution	NOUN
globalce-210	386	26	in	in	ADP
globalce-210	386	27	the	the	DET
globalce-210	386	28	healthcare	healthcare	NOUN
globalce-210	386	29	sector	sector	NOUN
globalce-210	386	30	.	.	PUNCT
globalce-210	386	31	biomed	biome	VERB
globalce-210	386	32	mat	mat	NOUN
globalce-210	386	33	devices	device	NOUN
globalce-210	386	34	.	.	PUNCT
globalce-210	387	1	2023;1:731–738	2023;1:731–738	NUM
globalce-210	387	2	.	.	X
globalce-210	387	3	https://doi.org/10.1007/s44174-023-00063-2	https://doi.org/10.1007/s44174-023-00063-2	NUM
globalce-210	387	4	.	.	PUNCT
globalce-210	388	1	46	46	NUM
globalce-210	388	2	.	.	PUNCT
globalce-210	389	1	henry	henry	PROPN
globalce-210	389	2	,	,	PUNCT
globalce-210	389	3	e.	e.	PROPN
globalce-210	389	4	and	and	CCONJ
globalce-210	389	5	thiel	thiel	PROPN
globalce-210	389	6	,	,	PUNCT
globalce-210	389	7	s.	s.	PROPN
globalce-210	389	8	using	use	VERB
globalce-210	389	9	existing	exist	VERB
globalce-210	389	10	regulatory	regulatory	ADJ
globalce-210	389	11	frameworks	framework	NOUN
globalce-210	389	12	to	to	PART
globalce-210	389	13	apply	apply	VERB
globalce-210	389	14	effective	effective	ADJ
globalce-210	389	15	design	design	NOUN
globalce-210	389	16	controls	control	NOUN
globalce-210	389	17	to	to	PART
globalce-210	389	18	ai	ai	VERB
globalce-210	389	19	/	/	SYM
globalce-210	389	20	ml	ml	X
globalce-210	389	21	in	in	ADP
globalce-210	389	22	medical	medical	ADJ
globalce-210	389	23	devices	device	NOUN
globalce-210	389	24	.	.	PUNCT
globalce-210	390	1	biomed	biome	VERB
globalce-210	390	2	instrum	instrum	ADV
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globalce-210	390	4	.	.	PUNCT
globalce-210	391	1	2022;56(4):114–118	2022;56(4):114–118	NUM
globalce-210	391	2	.	.	PUNCT
globalce-210	392	1	https://doi.org/10.2345/0899-8205-56.4.114	https://doi.org/10.2345/0899-8205-56.4.114	PROPN
globalce-210	392	2	.	.	PUNCT
globalce-210	393	1	47	47	NUM
globalce-210	393	2	.	.	PUNCT
globalce-210	394	1	palaniappan	palaniappan	PROPN
globalce-210	394	2	,	,	PUNCT
globalce-210	394	3	k.	k.	PROPN
globalce-210	394	4	,	,	PUNCT
globalce-210	394	5	lin	lin	PROPN
globalce-210	394	6	,	,	PUNCT
globalce-210	394	7	e.y.t	e.y.t	PROPN
globalce-210	394	8	,	,	PUNCT
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globalce-210	394	10	,	,	PUNCT
globalce-210	394	11	s.	s.	PROPN
globalce-210	394	12	global	global	ADJ
globalce-210	394	13	regulatory	regulatory	ADJ
globalce-210	394	14	frameworks	framework	NOUN
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globalce-210	394	16	the	the	DET
globalce-210	394	17	use	use	NOUN
globalce-210	394	18	of	of	ADP
globalce-210	394	19	artificial	artificial	ADJ
globalce-210	394	20	intelligence	intelligence	NOUN
globalce-210	394	21	(	(	PUNCT
globalce-210	394	22	ai	ai	NOUN
globalce-210	394	23	)	)	PUNCT
globalce-210	394	24	in	in	ADP
globalce-210	394	25	the	the	DET
globalce-210	394	26	healthcare	healthcare	NOUN
globalce-210	394	27	services	service	NOUN
globalce-210	394	28	sector	sector	NOUN
globalce-210	394	29	.	.	PUNCT
globalce-210	395	1	healthcare	healthcare	PROPN
globalce-210	395	2	.	.	PUNCT
globalce-210	396	1	2024;12(5):562	2024;12(5):562	NOUN
globalce-210	396	2	.	.	PUNCT
globalce-210	397	1	https://doi.org/10.3390/healthcare12050562	https://doi.org/10.3390/healthcare12050562	PROPN
globalce-210	397	2	.	.	PUNCT
globalce-210	398	1	48	48	NUM
globalce-210	398	2	.	.	PUNCT
globalce-210	398	3	center	center	NOUN
globalce-210	398	4	for	for	ADP
globalce-210	398	5	devices	device	NOUN
globalce-210	398	6	and	and	CCONJ
globalce-210	398	7	radiological	radiological	ADJ
globalce-210	398	8	health	health	NOUN
globalce-210	398	9	.	.	PUNCT
globalce-210	399	1	(	(	PUNCT
globalce-210	399	2	2022	2022	NUM
globalce-210	399	3	,	,	PUNCT
globalce-210	399	4	september	september	PROPN
globalce-210	399	5	26	26	NUM
globalce-210	399	6	)	)	PUNCT
globalce-210	399	7	.	.	PUNCT
globalce-210	400	1	digital	digital	PROPN
globalce-210	400	2	health	health	PROPN
globalce-210	400	3	software	software	PROPN
globalce-210	400	4	precertification	precertification	NOUN
globalce-210	400	5	(	(	PUNCT
globalce-210	400	6	pre	pre	ADJ
globalce-210	400	7	-	-	ADJ
globalce-210	400	8	cert	cert	ADJ
globalce-210	400	9	)	)	PUNCT
globalce-210	400	10	pilot	pilot	NOUN
globalce-210	400	11	program	program	NOUN
globalce-210	400	12	.	.	PUNCT
globalce-210	401	1	u.s	u.s	PROPN
globalce-210	401	2	.	.	PROPN
globalce-210	401	3	food	food	PROPN
globalce-210	401	4	and	and	CCONJ
globalce-210	401	5	drug	drug	PROPN
globalce-210	401	6	administration	administration	NOUN
globalce-210	401	7	.	.	PUNCT
globalce-210	402	1	available	available	ADJ
globalce-210	402	2	online	online	ADV
globalce-210	402	3	:	:	PUNCT
globalce-210	403	1	https://www.fda	https://www.fda	PROPN
globalce-210	403	2	.	.	PUNCT
globalce-210	404	1	gov	gov	PROPN
globalce-210	404	2	/	/	SYM
globalce-210	404	3	medical	medical	ADJ
globalce-210	404	4	-	-	PUNCT
globalce-210	404	5	devices	device	NOUN
globalce-210	404	6	/	/	SYM
globalce-210	404	7	digital	digital	ADJ
globalce-210	404	8	-	-	PUNCT
globalce-210	404	9	health	health	NOUN
globalce-210	404	10	-	-	PUNCT
globalce-210	404	11	center	center	NOUN
globalce-210	404	12	-	-	PUNCT
globalce-210	404	13	excellence/	excellence/	NUM
globalce-210	404	14	digital	digital	ADJ
globalce-210	404	15	-	-	PUNCT
globalce-210	404	16	health	health	NOUN
globalce-210	404	17	-	-	PUNCT
globalce-210	404	18	software	software	NOUN
globalce-210	404	19	-	-	PUNCT
globalce-210	404	20	precertification	precertification	NOUN
globalce-210	404	21	-	-	PUNCT
globalce-210	404	22	pre	pre	NOUN
globalce-210	404	23	-	-	ADJ
globalce-210	404	24	cert	cert	ADJ
globalce-210	404	25	-	-	PUNCT
globalce-210	404	26	pilot	pilot	NOUN
globalce-210	404	27	-	-	PUNCT
globalce-210	404	28	program	program	NOUN
globalce-210	404	29	.	.	PUNCT
globalce-210	405	1	49	49	NUM
globalce-210	405	2	.	.	PUNCT
globalce-210	406	1	gerke	gerke	NOUN
globalce-210	406	2	,	,	PUNCT
globalce-210	406	3	s.	s.	PROPN
globalce-210	406	4	,	,	PUNCT
globalce-210	406	5	minssen	minssen	PROPN
globalce-210	406	6	,	,	PUNCT
globalce-210	406	7	t.	t.	PROPN
globalce-210	406	8	,	,	PUNCT
globalce-210	406	9	cohen	cohen	PROPN
globalce-210	406	10	,	,	PUNCT
globalce-210	406	11	g.	g.	PROPN
globalce-210	406	12	ethical	ethical	ADJ
globalce-210	406	13	and	and	CCONJ
globalce-210	406	14	legal	legal	ADJ
globalce-210	406	15	challenges	challenge	NOUN
globalce-210	406	16	of	of	ADP
globalce-210	406	17	artificial	artificial	ADJ
globalce-210	406	18	intelligence	intelligence	NOUN
globalce-210	406	19	-	-	PUNCT
globalce-210	406	20	driven	drive	VERB
globalce-210	406	21	healthcare	healthcare	NOUN
globalce-210	406	22	.	.	PUNCT
globalce-210	407	1	artificial	artificial	ADJ
globalce-210	407	2	intelligence	intelligence	NOUN
globalce-210	407	3	in	in	ADP
globalce-210	407	4	healthcare	healthcare	PROPN
globalce-210	407	5	(	(	PUNCT
globalce-210	407	6	1st	1st	PROPN
globalce-210	407	7	edition	edition	PROPN
globalce-210	407	8	)	)	PUNCT
globalce-210	407	9	;	;	PUNCT
globalce-210	407	10	bohr	bohr	PROPN
globalce-210	407	11	,	,	PUNCT
globalce-210	407	12	a.	a.	NOUN
globalce-210	407	13	and	and	CCONJ
globalce-210	407	14	memarzadeh	memarzadeh	PROPN
globalce-210	407	15	,	,	PUNCT
globalce-210	407	16	k.	k.	PROPN
globalce-210	407	17	(	(	PUNCT
globalce-210	407	18	eds.);2020:295–336	eds.);2020:295–336	NOUN
globalce-210	407	19	.	.	PUNCT
globalce-210	408	1	https://	https://	PROPN
globalce-210	408	2	doi.org/10.1016/b978-0-12-818438-7.00012-5	doi.org/10.1016/b978-0-12-818438-7.00012-5	PROPN
globalce-210	408	3	.	.	PUNCT
globalce-210	409	1	https://resource.ddregpharma.com/blogs/regulatory-guidelines-for-software-and-artificial-intelligence-as-a-medical-device/	https://resource.ddregpharma.com/blogs/regulatory-guidelines-for-software-and-artificial-intelligence-as-a-medical-device/	PROPN
globalce-210	409	2	https://resource.ddregpharma.com/blogs/regulatory-guidelines-for-software-and-artificial-intelligence-as-a-medical-device/	https://resource.ddregpharma.com/blogs/regulatory-guidelines-for-software-and-artificial-intelligence-as-a-medical-device/	PROPN
globalce-210	409	3	https://resource.ddregpharma.com/blogs/regulatory-guidelines-for-software-and-artificial-intelligence-as-a-medical-device/	https://resource.ddregpharma.com/blogs/regulatory-guidelines-for-software-and-artificial-intelligence-as-a-medical-device/	VERB
globalce-210	409	4	https://cdsco.gov.in/opencms/resources/uploadcdscoweb/2018/uploadtenderfile/corrigendum_to_cdsco_eoi_ssp_01st_dec.pdf	https://cdsco.gov.in/opencms/resources/uploadcdscoweb/2018/uploadtenderfile/corrigendum_to_cdsco_eoi_ssp_01st_dec.pdf	PROPN
globalce-210	409	5	https://cdsco.gov.in/opencms/resources/uploadcdscoweb/2018/uploadtenderfile/corrigendum_to_cdsco_eoi_ssp_01st_dec.pdf	https://cdsco.gov.in/opencms/resources/uploadcdscoweb/2018/uploadtenderfile/corrigendum_to_cdsco_eoi_ssp_01st_dec.pdf	PROPN
globalce-210	409	6	https://cdsco.gov.in/opencms/resources/uploadcdscoweb/2018/uploadtenderfile/corrigendum_to_cdsco_eoi_ssp_01st_dec.pdf	https://cdsco.gov.in/opencms/resources/uploadcdscoweb/2018/uploadtenderfile/corrigendum_to_cdsco_eoi_ssp_01st_dec.pdf	PROPN
globalce-210	409	7	https://www.freyrsolutions.com/blog/regulation-of-software-as-medical-device-samd-in-india	https://www.freyrsolutions.com/blog/regulation-of-software-as-medical-device-samd-in-india	NUM
globalce-210	409	8	https://www.freyrsolutions.com/blog/regulation-of-software-as-medical-device-samd-in-india	https://www.freyrsolutions.com/blog/regulation-of-software-as-medical-device-samd-in-india	NUM
globalce-210	409	9	https://www.imdrf.org/sites/default/files/2024-04/imdrf%20grrp%20wg%20n47%20%28edition%202%29.pdf	https://www.imdrf.org/sites/default/files/2024-04/imdrf%20grrp%20wg%20n47%20%28edition%202%29.pdf	NUM
globalce-210	409	10	https://www.imdrf.org/sites/default/files/2024-04/imdrf%20grrp%20wg%20n47%20%28edition%202%29.pdf	https://www.imdrf.org/sites/default/files/2024-04/imdrf%20grrp%20wg%20n47%20%28edition%202%29.pdf	NUM
globalce-210	409	11	https://www.imdrf.org/sites/default/files/2024-04/imdrf%20grrp%20wg%20n47%20%28edition%202%29.pdf	https://www.imdrf.org/sites/default/files/2024-04/imdrf%20grrp%20wg%20n47%20%28edition%202%29.pdf	NUM
globalce-210	409	12	https://www.imdrf.org/sites/default/files/2024-04/imdrf%20grrp%20wg%20n71%20%28edition%202%29_0.pdf	https://www.imdrf.org/sites/default/files/2024-04/imdrf%20grrp%20wg%20n71%20%28edition%202%29_0.pdf	PROPN
globalce-210	409	13	https://www.imdrf.org/sites/default/files/2024-04/imdrf%20grrp%20wg%20n71%20%28edition%202%29_0.pdf	https://www.imdrf.org/sites/default/files/2024-04/imdrf%20grrp%20wg%20n71%20%28edition%202%29_0.pdf	PROPN
globalce-210	409	14	https://www.imdrf.org/sites/default/files/2024-04/imdrf%20grrp%20wg%20n71%20%28edition%202%29_0.pdf	https://www.imdrf.org/sites/default/files/2024-04/imdrf%20grrp%20wg%20n71%20%28edition%202%29_0.pdf	PROPN
globalce-210	409	15	https://www.imdrf.org/sites/default/files/2024-04/imdrf%20grrp%20wg%20n52%20%28edition%202%29.pdf	https://www.imdrf.org/sites/default/files/2024-04/imdrf%20grrp%20wg%20n52%20%28edition%202%29.pdf	PROPN
globalce-210	409	16	https://www.imdrf.org/sites/default/files/2024-04/imdrf%20grrp%20wg%20n52%20%28edition%202%29.pdf	https://www.imdrf.org/sites/default/files/2024-04/imdrf%20grrp%20wg%20n52%20%28edition%202%29.pdf	PROPN
globalce-210	409	17	https://www.imdrf.org/sites/default/files/2024-04/imdrf%20grrp%20wg%20n52%20%28edition%202%29.pdf	https://www.imdrf.org/sites/default/files/2024-04/imdrf%20grrp%20wg%20n52%20%28edition%202%29.pdf	PROPN
globalce-210	409	18	https://doi.org/10.1038/s41591-021-01614-0	https://doi.org/10.1038/s41591-021-01614-0	PROPN
globalce-210	409	19	https://doi.org/10.1038/s41591-021-01614-0	https://doi.org/10.1038/s41591-021-01614-0	PROPN
globalce-210	409	20	https://www.theseus.fi/bitstream/handle/10024/506136/nawar_bushra_2021_comparative%20analysis%20of%20artificial%20intelligence%20on%20medical%20device%20regulations%20and%20legislation%20in%20us%20and%20eu.pdf?sequence=2	https://www.theseus.fi/bitstream/handle/10024/506136/nawar_bushra_2021_comparative%20analysis%20of%20artificial%20intelligence%20on%20medical%20device%20regulations%20and%20legislation%20in%20us%20and%20eu.pdf?sequence=2	NOUN
globalce-210	409	21	https://www.theseus.fi/bitstream/handle/10024/506136/nawar_bushra_2021_comparative%20analysis%20of%20artificial%20intelligence%20on%20medical%20device%20regulations%20and%20legislation%20in%20us%20and%20eu.pdf?sequence=2	https://www.theseus.fi/bitstream/handle/10024/506136/nawar_bushra_2021_comparative%20analysis%20of%20artificial%20intelligence%20on%20medical%20device%20regulations%20and%20legislation%20in%20us%20and%20eu.pdf?sequence=2	PROPN
globalce-210	409	22	https://www.theseus.fi/bitstream/handle/10024/506136/nawar_bushra_2021_comparative%20analysis%20of%20artificial%20intelligence%20on%20medical%20device%20regulations%20and%20legislation%20in%20us%20and%20eu.pdf?sequence=2	https://www.theseus.fi/bitstream/handle/10024/506136/nawar_bushra_2021_comparative%20analysis%20of%20artificial%20intelligence%20on%20medical%20device%20regulations%20and%20legislation%20in%20us%20and%20eu.pdf?sequence=2	PROPN
globalce-210	409	23	https://www.theseus.fi/bitstream/handle/10024/506136/nawar_bushra_2021_comparative%20analysis%20of%20artificial%20intelligence%20on%20medical%20device%20regulations%20and%20legislation%20in%20us%20and%20eu.pdf?sequence=2	https://www.theseus.fi/bitstream/handle/10024/506136/nawar_bushra_2021_comparative%20analysis%20of%20artificial%20intelligence%20on%20medical%20device%20regulations%20and%20legislation%20in%20us%20and%20eu.pdf?sequence=2	PROPN
globalce-210	409	24	https://www.theseus.fi/bitstream/handle/10024/506136/nawar_bushra_2021_comparative%20analysis%20of%20artificial%20intelligence%20on%20medical%20device%20regulations%20and%20legislation%20in%20us%20and%20eu.pdf?sequence=2	https://www.theseus.fi/bitstream/handle/10024/506136/nawar_bushra_2021_comparative%20analysis%20of%20artificial%20intelligence%20on%20medical%20device%20regulations%20and%20legislation%20in%20us%20and%20eu.pdf?sequence=2	PROPN
globalce-210	409	25	https://www.theseus.fi/bitstream/handle/10024/506136/nawar_bushra_2021_comparative%20analysis%20of%20artificial%20intelligence%20on%20medical%20device%20regulations%20and%20legislation%20in%20us%20and%20eu.pdf?sequence=2	https://www.theseus.fi/bitstream/handle/10024/506136/nawar_bushra_2021_comparative%20analysis%20of%20artificial%20intelligence%20on%20medical%20device%20regulations%20and%20legislation%20in%20us%20and%20eu.pdf?sequence=2	PROPN
globalce-210	409	26	https://www.ey.com/en_gl/insights/law/how-the-challenge-of-regulating-ai-in-healthcare-is-escalating	https://www.ey.com/en_gl/insights/law/how-the-challenge-of-regulating-ai-in-healthcare-is-escalate	VERB
globalce-210	409	27	https://www.ey.com/en_gl/insights/law/how-the-challenge-of-regulating-ai-in-healthcare-is-escalating	https://www.ey.com/en_gl/insights/law/how-the-challenge-of-regulating-ai-in-healthcare-is-escalate	VERB
globalce-210	409	28	https://doi.org/10.1093/jlb/lsae007	https://doi.org/10.1093/jlb/lsae007	PROPN
globalce-210	409	29	https://doi.org/10.1093/jlb/lsae007	https://doi.org/10.1093/jlb/lsae007	VERB
globalce-210	409	30	https://doi.org/10.1145/3531146.3533158	https://doi.org/10.1145/3531146.3533158	NOUN
globalce-210	409	31	https://doi.org/10.1001/jama.2019.21579	https://doi.org/10.1001/jama.2019.21579	PROPN
globalce-210	409	32	https://doi.org/10.1007/s44174-023-00063-2	https://doi.org/10.1007/s44174-023-00063-2	NUM
globalce-210	410	1	https://doi.org/10.2345/0899-8205-56.4.114	https://doi.org/10.2345/0899-8205-56.4.114	PROPN
globalce-210	410	2	https://doi.org/10.3390/healthcare12050562	https://doi.org/10.3390/healthcare12050562	PROPN
globalce-210	410	3	https://www.fda.gov/medical-devices/digital-health-center-excellence/digital-health-software-precertification-pre-cert-pilot-program	https://www.fda.gov/medical-devices/digital-health-center-excellence/digital-health-software-precertification-pre-cert-pilot-program	PROPN
globalce-210	410	4	https://www.fda.gov/medical-devices/digital-health-center-excellence/digital-health-software-precertification-pre-cert-pilot-program	https://www.fda.gov/medical-devices/digital-health-center-excellence/digital-health-software-precertification-pre-cert-pilot-program	PROPN
globalce-210	410	5	https://www.fda.gov/medical-devices/digital-health-center-excellence/digital-health-software-precertification-pre-cert-pilot-program	https://www.fda.gov/medical-devices/digital-health-center-excellence/digital-health-software-precertification-pre-cert-pilot-program	PROPN
globalce-210	410	6	https://doi.org/10.1016/b978-0-12-818438-7.00012-5	https://doi.org/10.1016/b978-0-12-818438-7.00012-5	ADJ
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