Threats and Opportunities for the Clinical Investigation of High-risk Medical Devices in the Context of the New European Regulations

Author:

Pazart L.12,Pelayo S.13,Chevallier T.14,Gruionu G.56,Mabo P.17,Bayon Y.8,Barbot F.19,Lihoreau T.12,Roussel C.110,Maglaveras N.11,Lekka E.11,Ferreira H.12,Rocha I.13,Geris L.14,Lavet C.1

Affiliation:

1. Inserm, Tech4Health, FCRIN F-31000 Toulouse, France, --- Select a Country ---

2. Univ. Franche-Comté, Inserm CIC1431, CHU Besançon, F-25000 Besançon, France, --- Select a Country ---

3. Univ. Lille, Inserm, CHU Lille, ULR 2694, METRICS, F-59000 Lille, France, --- Select a Country ---

4. IDIL- Nimes University Hospital and INSERM IDESP, F-30000, Nimes, France, --- Select a Country ---

5. Krannert Institute of Cardiology, Indiana University School of Medicine, Indianapolis, IN 46202, U.S.A., --- Select a Country ---

6. INCESA Institute, Faculty of Mechanics, University of Craiova, Craiova 200512, Romania, --- Select a Country ---

7. Univ. Rennes, CHU de Rennes, Rennes, France, --- Select a Country ---

8. Medtronic, Sofradim Production, Trévoux, France, --- Select a Country ---

9. CIC 1429 Inserm, Hôpital Raymond Poincaré APHP, Garches, France, --- Select a Country ---

10. CIC 1415, CHU Tours, Inserm, University of Tours, France, --- Select a Country ---

11. Lab of Medical Informatics, Aristotle University of Thessaloniki, Thessaloniki, Greece, --- Select a Country ---

12. Instituto de Biofísica e Engenharia Biomédica, Faculdade de Ciências da Universidade de Lisboa, Portugal, --- Select a Country ---

13. Lisbon School of Medicine & Cardiovascular Centre, Universidade de Lisboa, Lisboa, Portugal, --- Select a Country ---

14. Biomechanics Research Unit, GIGA In Silico Medicine, University of Liège, Belgium, --- Select a Country ---

Publisher

SCITEPRESS - Science and Technology Publications

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