European medical devices regulation: a plea for ensuring safety without slowing access to innovation

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Bibliographic Details
Published in:Journal of shoulder and elbow surgery 2025-01, Vol.34 (1), p.332-336
Main Authors: Peñarrubia-Ortiz, Salvador, Calvo, Emilio
Format: Article
Language:English
Subjects:
European Database on Medical Devices (EUDAMED)
European Union
Food and Drug Administration
general safety and performance requirements
Medical device regulation
postmarket clinical follow-up
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Online Access:Get full text
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ISSN:1058-2746
1532-6500
1532-6500
DOI:10.1016/j.jse.2024.08.011