









































J Global Clinical Engineering Vol.2 Issue 3: 2020  8

Received February 18, 2020, accepted April 14, 2020, date of publication May 4, 2020

Quality Certification of Medical Devices in Venezuela: 
Process Developed by Simón Bolívar University, 
Caracas-Venezuela 
By R Mijares,1 N. Utrera,2 Z. Sierra,1 S. González,2 R. Lugo,2 M. Rincón,3 R. Mijares4  
1 Simón Bolívar University, Health Technology Management Unit (UGTS), Caracas, Venezuela
2 Simón Bolívar University, Department of Biological and Biochemical Processes, Caracas, Venezuela
3 Shell Venezuela, Hiring and Procurement, Caracas, Venezuela
4 Shanahan´s, Project Coordinator, Calgary, Canadá

ABSTRACT
Background and Objective: The development of medical technology and advances in biomedical engineering are in constant 
growth. Every year new medical devices are found in the market that seeks to satisfy the demand and requirements of medical 
services in health institutions. Consequently, health systems of the countries generate methodologies to regulate and accredit 
medical devices that really satisfy the needs of medical services with safety, effectiveness, efficiency, and quality. A third party 
must guarantee the safety and effectiveness of medical technology and issue a quality certification before its available to use 
in medical establishments. In Venezuela, one of the institutions authorized by the regulatory entity (Ministry of Health) that 
grants quality certification to medical devices is the Health Technology Management Unit (UGTS in Spanish), attached to the 
Research and Development Foundation (FUNINDES) of the Simón Bolívar University (USB). The objective of this work is to 
show the protocol for UGTS certification to comply with ISO 9001 standards and guarantee the quality of the processes of the 
medical devices certifying unit.
Material and Methods: The process is based on the ISO 9001 standard. Five activities were determined: (i) Prepare the teach-
ing, technical and administrative staff as ISO auditors. (ii) Carry out an external audit, to make proposals for improvement; (iii) 
Plan changes in our quality management system and processes and qualify as a supplier guided by the ISO 9001 philosophy by 
a prestigious international company; (iv) Submit our capabilities and to the Ministry of Health, and (v) Execute the protocol to 
certify medical devices.Medical devices certification includes the analysis not only of the devices itself but the manufacturer, 
distributor, and post-market services. All these stages and stakeholders are evaluated in the certification process per the guide-
lines established by the ISO 9001 standard.
Results: The UGTS has developed a protocol that guarantees the safety and effectiveness of new medical devices before its use 
in the Venezuelan health care system. The protocol is based on the national and international regulations; it has been evaluated 
by Johnson & Johnson Medical S.C.S. and the UGTS it has been approved as a supplier for the analysis of medical devices by the 
company in complying with ISO 9001 Standard. Under this new protocol, 550 medical devices have been certified.
Conclusions: Advance on technology allows the breakthrough in medical device development. It is important to acknowledge 
the need to incorporate less invasive, more accurate and effective devices, in which physicians often rely on to treat a patient, 
but also developers must be compelled to meet the bioethical principles. The UGTS protocol to certify medical devices is had 
been recognized and the unit is authorized by the Ministry of Health (MPPS) through the Sanitary Comptroller's Office to issue 
quality certificates to medical teams since 1999. Approximately 55 companies that have received service are registered in its 
database. In the period audited (2012 - 2014), 25 files were created. Its processes comply with ISO 9001.

Keywords – Quality, Certification, Medical Devices, Processes, and Food and Drugs Administration. 
Copyright © 2021. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY): Creative Commons - Attribution 4.0 International 
- CC BY 4.0. The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original 
publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

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devices.Medical


9 J Global Clinical Engineering Vol.2 Issue 3: 2020

Mijares, Utrera, Sierra, González, Lugo, Rincón, Mijares: Quality Certification of Medical Devices in Venezuela: Process 
Developed by Simón Bolívar University, Caracas-Venezuela 

INTRODUCTION
Medical devices and supplies increase productivity 

in health institutions, contributing to the reduction of 
morbidity and mortality rates; however, the use of medi-
cal devices has an associated risk. Also, with the advance 
of technology medical-device complexity had increased 
over time, representing a challenge to the health system 
to keep on track.1–3

Currently, there is a great diversity of medical devices, 
due to the increasing technological and biomedical advances 
and developments which make it possible to improve the 
diagnosis and treatment of pathologies, and thus improve 
the quality and efficiency of medical care services.4 Gov-
ernmental health systems seek mechanisms to regulate 
the acquisition of these medical devices, to ensure that 
their use effectively complements quality medical service.

According to the Food and Drugs Administration 
(FDA), equipment or medical device is Instrument, de-
vice, implement, machine, implant, or other similar or 
related article, including a component, part, or accessory, 
designed for (1) The use in the diagnosis of a disease or 
other conditions, or the cure, mitigation, treatment, or 
prevention of disease in humans or animals; (2) Affecting 
the structure or any function of the body of humans or 
animals, without this being done from chemical processes 
and without depending on human or animal metabolism 
to obtain the desired result.5

The definition presented shows the amplitude of the 
concept since it includes different teams whose functions 
vary. Medical equipment can range from a simple ther-
mometer to complex angiography equipment, and both 
its manufacturing and the complexity of the technology 
are increasing. A 17.4% growth in employment related 
to all areas of health including prevention, diagnosis, 
monitoring, treatment, and care is expected.6 Growth 
will also thrive in the healthcare manufacturing industry.

Internationally it is considered that all equipment or 
material for use in human medicine should be subject 
to registration and control by the health authorities of 
the country of origin to ensure that such equipment or 
material is "safe and effective."7 

In Venezuela, the registration and control of medical 
materials and equipment is regulated by Resolution No. 

DM-001 0-99 dated September 21, 1997. Article 1 of 
the resolution establishes that: "Every juridical person 
constituted in Venezuela interested in manufacturing, 
importing, marketing or providing maintenance services 
of materials and equipment for use at the levels of the 
health area, must previously register in the National 
Sanitary Registry that the Directorate of Regulation and 
Control of Materials, Equipment, Establishments and 
Health Professions carries out, attached to the General 
Directorate of Health Controllership of the Ministry of 
Popular Power for Health (MPPS).8

Article 4 states that: "The materials and equipment 
used in the area of human health must be registered in the 
corresponding Directorate of this Ministry contemplated 
in Article 1 of this Resolution." Among the requirements 
required to obtain such registration, the interested party 
must present a Quality Certification issued by an accred-
ited institution (Article 6, paragraph f).8

To satisfy this legality, the Venezuelan State has au-
thorized institutions, which have the infrastructure and 
specialized personnel to guarantee the processes that 
allow issuing the appropriate certificate, based on the 
aforementioned principle of "safety and effectiveness." 
Among these institutions is the Health Technology Man-
agement Unit attached to the Research and Development 
Foundation of the Simón Bolívar University, which is also 
part of the Biophysics and Bioengineering Group and is 
an active part of the Biophysics Laboratory.8,9

The safety of medical equipment and material is 
subject to the criteria of the evaluating specialist and its 
effectiveness will depend on fulfilling the functions for 
which it was designed and constructed, according to the 
manufacturer's technical specifications (that is, that the 
device does what it says it must do). These two aspects 
constitute the elements of judgment to issue the quality 
certificate.7

Additionally, any process developed by an organization, 
to be recognized must have approval of the International 
Organization for Standardization (ISO). ISO creates docu-
ments that provide requirements, specifications, guide-
lines or features that can be used consistently to ensure 
that the materials, products, processes, and services are 
suitable for their purpose.10



Mijares, Utrera, Sierra, González, Lugo, Rincón, Mijares: Quality Certification of Medical Devices in Venezuela: Process 
Developed by Simón Bolívar University, Caracas-Venezuela 

J Global Clinical Engineering Vol.2 Issue 3: 2020  10

One of the families of the ISO standards is the one 
called ISO 9001. ISO 9001: 2015 establishes the criteria 
for a quality management system and is the only standard 
in the family that can be certified (although this is not a 
requirement). It can be used by any organization, large 
or small, regardless of its field of activity. There are more 
than one million companies and organizations in more 
than 170 countries certified with ISO 9001.

This standard is based on a series of quality manage-
ment principles that include a strong focus on the client, 
the motivation and involvement of top management, the 
process approach and continuous improvement. The use 
of ISO 9001: 2015 helps ensure that customers obtain 
consistent, high-quality products and services, which in 
turn provide many business benefits.11

The general objective of the work was to show how the 
UGTS comply with the requirements of the ISO 9001 Standard 
in the Quality Certification processes for medical devices 
in Venezuela to guarantee the highest possible quality in 
each evaluation process of the biomedical technologies 
that are intended to be commercialized in Venezuelan 
territory. The specific objectives were: (A) To prepare 
the teaching, technical and administrative personnel as 
internal auditors ISO 9001; (B) Request the execution of 
an external audit, to make proposals for improvement; 
(C) Plan changes in our quality management system and 
processes; and (D) Qualify as an ISO 9001 approved sup-
plier by a prestigious international company.

METHODOLOGY
The research performed was a qualitative study, and was 

exploratory and descriptive according to its purpose.12,13 

According to its source, the work is documentary. Informa-
tion was collected from primary and secondary sources. 
The design of the research is not experimental and from a 
temporal point of view is longitudinal. Its analysis unit is 
the process of quality certification of medical equipment 
implemented by the UGTS-USB. Within the aforementioned 
process, a series of requirements were identified that 
must be met for the process to be effective.

RESULTS AND DISCUSSION

Preparation of Staff
  The UGTS met with all staff (teaching, technical and 

administrative) in January 2014 and assumed the com-
mitment over the quality management system as its work 
philosophy. That same year, two courses were held on 
this Standard, totaling 112 hours of classes to become 
"ISO 9001 Auditors." Subsequently, in 2015, the same 
personnel carried out three courses on ISO 13485 with 
a duration of 60 hours. 

  ISO 13485 of Medical Equipment is an internation-
ally recognized quality management system (QMS) for 
manufacturers of medical equipment and related services. 
The main objective of the standard is to establish a set 
of harmonized regulatory requirements for QMSs within 
the sector of medical devices. It is based on ISO 9001, 
especially on the requirements of customer satisfaction 
and continuous improvement, but with modifications to 
make them more appropriate to the regulatory objective.14

After Staff Preparation
After the preparation of the UGTS staff an external 

audit of the certification processes that were being used 
since 1999 was requested. The audit was carried out by 
an external university (Metropolitan University) with a 
School of Production Engineering. Within this university, 
an expert professor in processes in health institutions 
was contacted and the field study became degree work 
for two students.15 

The conclusions of the audit it was found that the Min-
istry of Health Autonomous Health Comptroller Service 
does not have specific requirements established for the 
quality certification of medical equipment so that each 
accredited institution has freedom regarding the certifica-
tion process to carry out the evaluation. The requirements 
recommended by the Food and Drug Administration (FDA)16 
and the Pan American Health Organization (PAHO)17 
were studied. A review of the literature was carried out 
at the most important universities in Venezuela using 
the PubMed and LILACS databases and similar works 
were not obtained. There was no classification of medical 
equipment according to the level of risk they represent. 
There was no post-marketing surveillance of medical 



11 J Global Clinical Engineering Vol.2 Issue 3: 2020

Mijares, Utrera, Sierra, González, Lugo, Rincón, Mijares: Quality Certification of Medical Devices in Venezuela: Process 
Developed by Simón Bolívar University, Caracas-Venezuela 

equipment. Faults were identified in the requirements 
related to the technical documentation, specifically related 
to the capacity of the applicant company to give technical 
support to the equipment.

  Changes in the QMS
  To plan the changes in the QMS and its processes 

several activities were carried out. Once the results of 
the external audit were known, the UGTS adopted the 
classification of the FDA's medical equipment18 and began 
to request that companies that require the certificate in 
writing describing their capacity to give technical support 
for the equipment. The processes were as follows:
(i.) Company Documentation: Name of the Company; 

Person to contact; Address and telephone num-
bers of the company; Technical capacity; List of 
equipment to be certified with respective technical 
documentation (catalogs and technical sheets); 
Estimate of the approximate sale price; Written 
evidence of technical personnel that will perform 
after-sales service; Sanitary registry issued by the 
Ministry of Popular Power for Health of Venezuela. 
In cases where the company had never been evalu-
ated, we visited its facilities.

(ii.) Characteristics of the manufacturing company 
(of the equipment to be evaluated): Name of the 
Company; Address and telephone numbers of the 
company; Development areas; Technical capacity.

(iii.) If the equipment or instruments have a certificate 
from their country of origin, the most important 
being those of the FDA (USA), European Conformity 
(CE) according to Directive 93/68 / EEC, IEC 60601, 
ISO 13485 and ISO 9001, ISO 62353, the application 
must be accompanied by the documentation refer-
ring to the international certification. Copies of the 
standards taken as a basis for the issuance of such 
certificates, as well as of the free sale certificates 
issued in the country of origin should be included. 
The required copies must be in Spanish or English 
and duly legalized by the Consulate or Venezuelan 
Embassy in the country of origin. In addition, the 
applicant must issue a letter committing to supply 
the required material and cancel the invoices for 
expenses generated during the certification process.

(iv.) For the issuance of the Certificate by the USB, the 
equipment must be operational in Venezuela so it 
can be verified by the specialists in clinical engineer-
ing and medicine. If the equipment is not located 
in Venezuela and the documentation presented 
meets the requirements, a provisional certificate 
and a recommendation for its importation will 
be issued to the respective official body. Once the 
equipment enters the country and is operational, 
the technical visit will proceed, and the final cer-
tificate will be provided.

(v.) If the requesting person or company does not 
have the aforementioned documentation, if the 
equipment is manufactured locally, or there is a 
standard for the certification of the equipment 
and its accessories, the specialists of the USB will 
proceed with its study to define the protocol or 
design the set of tests required. The USB will notify 
the applicant about the materials and equipment 
that must be supplied to carry out the tests.

(vi.) If the documents presented are valid, or if it is 
feasible to initiate the procedures, after a thor-
ough evaluation of its contents and it contains all 
the sufficient elements required, the certification 
process will begin, and all interested parties will 
be notified. If, on the other hand, the documenta-
tion submitted does not meet all the requirements 
required by the Law, or the procedures are not 
feasible, the pertinent recommendations will be 
made and all the material will be returned.

(vii.) After carrying out these steps we will proceed to the 
analysis and decision-making regarding whether 
to guarantee or not the quality certificate to the 
medical team.

(viii.) After having the new QMS, a working meeting 
was requested with the Venezuelan Association 
of Distributors of Medical, Dental, Laboratory and 
Allied Equipment (AVEDEM),19 with the objective 
convey our impressions to our main clients. After 
the rigorous explanations, AVEDEM remained in 
agreement as it follows the guidelines of the main 
specialized agencies in the field.

The process is summarized in Figure 1.



Mijares, Utrera, Sierra, González, Lugo, Rincón, Mijares: Quality Certification of Medical Devices in Venezuela: Process 
Developed by Simón Bolívar University, Caracas-Venezuela 

J Global Clinical Engineering Vol.2 Issue 3: 2020  12

Qualifying as a Supplier Under the Performance Stan-
dards According to ISO 9001 

The prestigious transnational company Johnson 
& Johnson Medical S.C.S. requested that we in Bogotá 
(Colombia)20 conduct a remote audit to qualify them as 
an approved supplier for the certification service of its 
products in Venezuela. After completion, in January 2017 
they were informed that their services were based on the 
ISO 9001 standard.

Medical Device Certifications
Since 1999 more than 80 companies have requested 

medical device certifications from the UGTS, for one or 
more of the devices they manufacture, distribute, and sell 
in Venezuela. The UGTS have issued certification for over 
3000 medical devices since that year. After the incorpora-
tion of the ISO 9001 normative to the certification process 
in 2017, 550 medical devices were certified. These, more 
recent, certifications correspond to 4 companies with a 
greater number of devices grouped in families or series. 
Another aspect that has influenced the certification of 

FIGURE 1. Diagram of medical device certification stages. Each 
stage must be accomplished in order to advance to the next.

medical technologies in Venezuela is the Venezuela-China 
cooperation agreement,21 signed in 2013 which allows the 
acquisition, selling, distribution, and commercialization 
of medical technologies between these countries without 
the quality certification. Due to this agreement, the pres-
ence of Chinese technology in Venezuela, without quality 
certification, has increased during the past few years. 

The most recent 1200 medical devices certified by 
the UGTS are shown in a graphic form as classified by 
medical function (Figure 2). It is important to note that 
this classification is only for this paper as a reference of 
the certified technological diversity. Figure 2 and Table 
1 present the certified devices according to their main 
function. 

Some aesthetic devices that use radiofrequency and 
radiation emission are aimed to preserve or restore 
the health of the skin, as a consequence, they are also 

FIGURE 2. Certified medical devices classified by function.

TABLE 1. Certified Medical Devices Classified by Function



13 J Global Clinical Engineering Vol.2 Issue 3: 2020

Mijares, Utrera, Sierra, González, Lugo, Rincón, Mijares: Quality Certification of Medical Devices in Venezuela: Process 
Developed by Simón Bolívar University, Caracas-Venezuela 

considered medical devices. Diagnosis and monitoring 
medical devices include those that provide information 
directly related to pathology and biological variable 
registries such as electric signals, anatomical images, or 
metabolites concentration. Treatment and therapy medi-
cal devices are those designed to mitigate or eliminate 
the pathology or condition such as implants, nebulizers, 
hyperbaric chambers, or infusion pumps. Instrumental 
medical devices are all metallic reusable tools used dur-
ing surgeries. Disposable devices are those designed 
for single-use such as needles, injectors, and condoms. 
Auxiliaries and furniture are those devices that support a 
clinical procedure but are not directly in contact with the 
patient such as centrifuges, plasma extractors, operating 
room lamps, refrigeration and sterilization equipment, 
nebulization and oxygen masks, and clinical furniture 
(tables, clinical beds). Life support devices are those such 
as mechanical ventilators, anesthesia machines, neonatal 
cribs, defibrillators, and pacemakers.

CONCLUSIONS
The UGTS is certified by the standard ISO 9001:2015, 

which guarantees the quality operation of the unit that is 
authorized by the Ministry of Health through the Sanitary 
Comptroller's Office to issue quality certificates to medi-
cal teams since 1999.

The objective of the certifying UGTS team was to develop 
the protocols for action and verification, based on the ISO 
9001 standard, in the Quality Certification processes for 
medical devices in Venezuela.

To achieve this goal, the teaching, technical, and ad-
ministrative staff were prepared as internal ISO 9001 
auditors. An external audit was then requested to make 
proposals for improvement. Based on this audit, changes 
were made to the QMS and its processes and was im-
mediately made known to the clients. The clients were 
satisfied, as it follows the guidelines of the main special-
ized agencies in the field.

 Part of the UGTS staff was accredited as ISO 9001: 
2015 auditors enabling this protocol to be incorporated 
into the process of medical devices certification. This will 
guarantee the quality of the management systems of the 

companies involved in the manufacture, distribution, and 
post-market servicing of the intended technology. 

The importance of certification, as noted by Guberta 
and Badnjevic1 and Vukovic et al,22 suggested to the 
Ministry of Health there was a need for the existence of 
a clinical engineering unit in every health institution to 
continuously monitor the performance of medical devices.

Finally, the company Johnson & Johnson Medical 
S.C.S. requested an audit to qualify them as an approved 
supplier for the certification service of its products in 
Venezuela.20 After this was completed in January 2017 
we were informed that our services are based on the ISO 
9001 standard.23

Future work is oriented to the automation of the QMS 
protocol to go along with public policies aimed at paper-
less transactions at the Ministry of Health.

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