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Challenges faced by manufacturers with clinical evaluation under the new European Medical Device Regulations

AbstractThis study seeks to investigate the impact of strengthened requirements for clinical evaluation for medical device manufacturers in Europe due to the new Medical Device Regulations. Qualitative interviews were conducted with eight clinical evaluation consultants from eight different European...

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Détails bibliographiques
Auteurs principaux: Breda Kearney, Olivia McDermott
Format: Artigo
Langue:Inglês
Publié: Taylor & Francis Group 2023-12-01
Collection:Cogent Engineering
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Accès en ligne:https://www.tandfonline.com/doi/10.1080/23311916.2023.2261236
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