The role of biomechanical Engineering Laboratory (LEBm/HU-UFSC) in the pre-clinical evaluation of surgical implants technologies in the health-industrial complex

oleh: Carlos Rodrigo Roesler, Ari Digiácomo Ocampo Moré

Format: Article
Diterbitkan: Universidade Federal de Santa Catarina 2017-06-01

Deskripsi

The Biomechanics Engineering Laboratory (LEBm/HU-UFSC) is a reference center in education and research as well as in the technological development of the health field including pre-clinical testing of biomedical devices. The critical assessment of safety and effectiveness of biomedical devices requires a definition of clinically relevant metrics that allow quantifying the risks associated with their use. In Brazil, the National Health Surveillance Agency (ANVISA) controls the regulatory affairs and permission for commercialization of medical devices upon demonstration that the product is free from unacceptable risks. Therefore, achieve the minimum requirements for commercialization of products developed in Brazil are of utmost importance to the national industry and can positively impact on the trade balance of the Brazilian medical devices companies. In this paper the work of LEBm/HU-UFSC in the development of the medical devices field and in the formation of human resources for the pre-clinical evaluation of surgical implant technologies manufactured in Brazil is described.