A atuação do laboratório de Engenharia Biomecânica (LEBm/HU-UFSC) na  avaliação pré-clínica de tecnologias de implantes cirúrgicos no âmbito do complexo industrial da saúde

Carlos Rodrigo Roesler; Ari Digiácomo Ocampo Moré

doi:10.5007/1807-0221.2017v14n25p211

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

Authors

Carlos Rodrigo Roesler Universidade Federal de Santa Catarina
Ari Digiácomo Ocampo Moré Universidade Federal de Santa Catarina

DOI:

https://doi.org/10.5007/1807-0221.2017v14n25p211

Abstract

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.

Author Biographies

Carlos Rodrigo Roesler, Universidade Federal de Santa Catarina

Doutorado em Engenharia Mecânica pela Universidade Federal de Santa Catarina, Brasil(2006). Professor da Universidade Federal de Santa Catarina , Brasil

Ari Digiácomo Ocampo Moré, Universidade Federal de Santa Catarina

Possui Graduação em Medicina pela Universidade Federal de Santa Catarina (1976), Mestrado em Ortopedia e Traumatologia pela Universidade de São Paulo (1990), Doutorado em Medicina pela Universidade de São Paulo (1995). Pós-doutorado na University of California - Los Angeles - EUA. (1999). Professor do Departamento de Cirurgia da UFSC, desde 1984. Chefe do Serviço de Ortopedia e Traumatologia do Hospital Universitario e Coordenador de Área Médica do Laboratório de Engenharia Biomecânica do HU/UFSC.

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Published

2017-06-14

Issue

Vol. 14 No. 25 (2017): Revista Eletrônica de Extensão - Extensio

Section

TÓPICO ESPECIAL

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