| Autor: |
François Parquin, Antoine Audry, Bernard Avouac, Alexandre Barna, Catherine Denis, Bruno Frachet, Isabelle Fontes, Chrystelle Gastaldi, Jean-Claude Ghislain, Bernard Guillot, Muriel Granger, Anne Grumblat, Anne Josseran, Gérard Luzergues, Pierre-Olivier Marguet, Noël Martinet, Nadine Normand, null (AFNOR), Rémy Pécault, Sandrin Pitel, Françoise Roca, Fabrice Romano, Emilie Rufach, Dominique Thiveaud, Daniel Vasmant |
| Rok vydání: |
2012 |
| Předmět: |
|
| Zdroj: |
Therapie. 67(4) |
| ISSN: |
0040-5957 |
| Popis: |
The purpose of the Giens round table no. 1 was to make proposals and recommendations regarding the clinical evaluation of medical devices. First, the European and French regulatory rules were examined and compared with the US FDA approach. Thereafter, the main specificities and constraints of the MD sector were underlined and their impact in clinical evaluation described and analyzed. Two areas, cumulating most of these constraints, were consecutively analyzed for concrete case study. Considering a patient-centered approach, the RT issued eight recommendations directed to manufacturers, physicians and policymakers in order to improve clinical evaluation in the medical device field. |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
|
