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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Bibliographic Details
Published in:Cogent Engineering
Main Authors: Breda Kearney, Olivia McDermott
Format: Article
Language:English
Published: Taylor & Francis Group 2023-12-01
Subjects:
Online Access:https://www.tandfonline.com/doi/10.1080/23311916.2023.2261236