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

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 requi...

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Main Authors: Carlos Rodrigo Roesler, Ari Digiácomo Ocampo Moré
Format: Article
Language:Portuguese
Published: Universidade Federal de Santa Catarina 2017-06-01
Series:Extensio: Revista Eletrônica de Extensão
Subjects:
Online Access:https://periodicos.ufsc.br/index.php/extensio/article/view/51063
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author Carlos Rodrigo Roesler
Ari Digiácomo Ocampo Moré
author_facet Carlos Rodrigo Roesler
Ari Digiácomo Ocampo Moré
author_sort Carlos Rodrigo Roesler
collection DOAJ
description 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.
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spelling doaj.art-604b705bd81544f1aa0c27ee9a5c474c2022-12-21T19:06:51ZporUniversidade Federal de Santa CatarinaExtensio: Revista Eletrônica de Extensão1807-02212017-06-01142521122110.5007/1807-0221.2017v14n25p21127356The role of biomechanical Engineering Laboratory (LEBm/HU-UFSC) in the pre-clinical evaluation of surgical implants technologies in the health-industrial complexCarlos Rodrigo Roesler0Ari Digiácomo Ocampo Moré1Universidade Federal de Santa CatarinaUniversidade Federal de Santa CatarinaThe 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.https://periodicos.ufsc.br/index.php/extensio/article/view/51063Implantes OrtopédicosEnsaios Pré-ClínicosSegurança e EficáciaDesenvolvimento Tecnológico
spellingShingle Carlos Rodrigo Roesler
Ari Digiácomo Ocampo Moré
The role of biomechanical Engineering Laboratory (LEBm/HU-UFSC) in the pre-clinical evaluation of surgical implants technologies in the health-industrial complex
Extensio: Revista Eletrônica de Extensão
Implantes Ortopédicos
Ensaios Pré-Clínicos
Segurança e Eficácia
Desenvolvimento Tecnológico
title The role of biomechanical Engineering Laboratory (LEBm/HU-UFSC) in the pre-clinical evaluation of surgical implants technologies in the health-industrial complex
title_full The role of biomechanical Engineering Laboratory (LEBm/HU-UFSC) in the pre-clinical evaluation of surgical implants technologies in the health-industrial complex
title_fullStr The role of biomechanical Engineering Laboratory (LEBm/HU-UFSC) in the pre-clinical evaluation of surgical implants technologies in the health-industrial complex
title_full_unstemmed The role of biomechanical Engineering Laboratory (LEBm/HU-UFSC) in the pre-clinical evaluation of surgical implants technologies in the health-industrial complex
title_short The role of biomechanical Engineering Laboratory (LEBm/HU-UFSC) in the pre-clinical evaluation of surgical implants technologies in the health-industrial complex
title_sort role of biomechanical engineering laboratory lebm hu ufsc in the pre clinical evaluation of surgical implants technologies in the health industrial complex
topic Implantes Ortopédicos
Ensaios Pré-Clínicos
Segurança e Eficácia
Desenvolvimento Tecnológico
url https://periodicos.ufsc.br/index.php/extensio/article/view/51063
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