Quality Certification of Medical Devices in Venezuela: Process Developed by Simón Bolívar University, Caracas-Venezuela

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Rodrigo Mijares https://orcid.org/0000-0003-3284-9968
Néstor Utrera https://orcid.org/0000-0003-3274-7443
Zhayda Sierra
Sara González
Rubén Lugo
María Rincón
Raquel Mijares


Quality, Certification, Medical Device, Processes, Food and Drugs Administration


Background and objective: medical devices and supplies increase productivity in health institutions, contributing to the reduction of morbidity and mortality rates. However, the use of medical devices has an associated level of risk. A third party must guarantee the safety and effectiveness of the medical team to grant a quality certification. In Venezuela, one of the institutions authorized by the regulatory entity (Ministry of Popular Power for Health) that grants quality certification is the Health Technology Management Unit (UGTS) attached to the Research and Development Foundation (FUNINDES ) from the Simón Bolívar University (USB). The objective of this work is to show the certification protocol by the UGTS and its results.

Material and Methods; It based on the ISO 9001 standard for the processes. Five activities were determined: Prepare the teaching, technical and administrative staff as ISO auditors. Carry out an external audit, in order to make proposals for improvement; 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.

Results: Based on the results, general and particular proposals were proposed to improve the process. These were adopted by the group and later in the evaluation of an international company the USB was qualified as an approved supplier for the analysis of medical devices by the company Johnson & Johnson Medical S.C.S. when complying with ISO 9001 Standard.

Conclusions: The UGTS is authorized by the Ministry of Popular Power for 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.


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