Resumo

ACEVEDO LOPEZ, Juliana; SALDARRIAGA HERRERA, Nataly  e  GARCIAO, J. H. PROTOCOLS FOR VALIDATION OF MEDICAL TECHNOLOGY. Rev. ing. biomed. [online]. 2015, vol.9, n.18, pp.145-151. ISSN 1909-9762.

The companies producing technologies require a better understanding of the processes in providing services for medical devices, as well as the constant improvement of existing equipment to achieve a more productive and efficient transformation, involving the complete process of marketing new technologies, the rules applicable to processes, sales specific procedures, and technology features. The development of specific standards for each particular medical team is not easy, so it is important that all equipment functionality in the area of medicine before going to the market or already being in it, have an analysis to verify correct operation in order to protect and improve the quality of life, not only in patients, but also of all who are in constant contact with them. This article presents a methodology for designing validation protocols to medical technology; starting with a review of the rules and procedures applicable for international certification by FDA or INVIMA at national level; It is followed by a search of companies or laboratories that can perform the necessary tests and the design of protocols and checklists, for this, a series of tests on medical devices in order to check compliance with the standards set will be developed by different agencies responsible for monitoring and regulation of medical devices. Protocols for two medical teams were held and allowed the foundations for the development of similar protocols to other devices along the lines proposed in the methodology.

Palavras-chave : Standards; Biomedical Equipment; Design for Quality; Technology.

        · resumo em Português | Espanhol     · texto em Espanhol     · Espanhol ( pdf )