Model for management of the research process and development of products for health [Modelo para gestão do processo de pesquisa e desenvolvimento de produtos para saúde]

Abstract

Medical device or correlated products are widely used in different medical, dental, physiotherapy, beauty and diagnostic procedures. Those products may only be distributed after National Health Surveillance Agency (ANVISA) approval, which is obtained proving the product safety and effectiveness by the manufactory. Therefore it is important the companies follow standards and validated procedures for all stages of the product manufacturing, including the Research and Development (R&D) process. Moreover, this work proposes a policy and practice for R&D medical devices management process, in a way they can be conceived in compliance with the applicable legal requirements, including methods for monitoring its effectiveness and safety. This present work was written based on the current literature reference available on this subject, including specifics references about medical devices development. The result is a policy management which is able to manage different stages of the R&D medical devices process.