Órtese ativa para ela: proposta de um protocolo de boas práticas de fabricação com base na RDC n° 16/2013 para o projeto revELA no LAIS/UFRN

Abstract

In recent years, the number of academic research focused on medical devices has increased significantly, consequently the number of products developed in research centers as well. Establishing cooperation between universities and industries has many advantages for both institutions, mainly for the development of innovations, although there are already some consolidated initiatives (ex: Patents, Start-ups). However, there are still several barriers for products developed at universities to reach the patient. This is not only due to the bureaucratic excess of industries to install themselves in academic centers, but also, the research carried out in the laboratories does not take into account the same criteria for standardizing companies to manufacture a product and deliver it to the market. ANVISA requires companies to comply with Good Manufacturing Practices (GMP) so that products can reach the market. Suggesting that research centers start working with GMP, favors the launch of an innovative product to the market, with the due collaboration of the industries. Thus, this work aims to propose a GMP protocol based on that of RDC No. 16/2013 in the Laboratory of Technological Innovations in Health (LAIS), in the product “Active Orthosis for ALS” of the “project revELA”. The implantation method consisted of analyzing all chapters of the resolution and verifying which ones fit the reality of the laboratory. In evaluation, the steps involving packaging, labeling, distribution, complaints management, installation and technical assistance and statistical techniques are focused on procedures that involve the post-market, therefore, they were removed from the composition of this study. In addition, which technical standards could assist in complying with the resolution were analyzed, ABNT NBR ISO 13485/2016 and ABNT NBR ISSO 14971/2009 were chosen to develop the quality management system and risk management, respectively. Among the results, forms, documents, process layout and specifications and process flows were developed in accordance with what is required by the brazilian agency.