Guía de integración de la gestión de la calidad y la normativa legal colombiana para el diseño, desarrollo, fabricación, comercialización y exportación de dispositivos médicos clase I y IIa

Abstract

A guide is presented for the integration of the quality management system of class I and IIA medical devices and the regulatory aspects in the Colombian framework, applicable in the design, development, manufacture, commercialization and export of Medical Devices. An investigation of the current normogram was carried out in the databases of Invima and the Ministry of Health and Social Protection, the NTC-ISO 13485:2016 standard was reviewed; Inquiries were made in articles in electronic databases, technical consultations with Invima regarding the interpretation of the regulation and experts in the sector. This study and the application guide made it possible to identify methodologies and practical recommendations for the sector, by granting recommendations based on comments from experts in it, also leading to strengthening knowledge as a guide to medical device manufacturing companies in Colombia.