Cet article a un erratum : [https://doi.org/10.2515/therapie/2012077]
Volume 67, Numéro 4, Juillet-Août 2012
|Page(s)||311 - 318|
|Section||Innovation technologique / Technological Innovation|
|Publié en ligne||1 novembre 2012|
Clinical Evaluation of Medical Devices: Main Constraints and Specificities
Hospital, Suresnes, France
2 Medtronic France SAS, Boulogne, France
Correspondence and offprints: François Parquin, Respiratory Intensive Care Unit, Foch Hospital, BP 36, 92151 Suresnes Cedex, France. Email: firstname.lastname@example.org
Accepted: 4 June 2012
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.
Key words: medical device / clinical evaluation
© 2012 Société Française de Pharmacologie et de Thérapeutique