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
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 d...
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| Formato: | Dissertação |
| Idioma: | pt_BR |
| Publicado em: |
Universidade Federal do Rio Grande do Norte
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| Endereço do item: | https://repositorio.ufrn.br/handle/123456789/33319 |
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| Resumo: | 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. |
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