Randomized Registry Trials - efficient post market clinical follow-up for medical devices

In spite of advances in the treatment of cardiovascular disease, there remains a significant need for high-quality evidence for clinical practice given the rising prevalence worldwide. Next to the increase of regulatory requirements, poor screening-to-recruitment ratios, lack of patient engagement,...

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Bibliographic Details

Published in:	Current Directions in Biomedical Engineering
Main Authors:	Leuchter Matthias, Siewert Stefan, Stiehm Michael, Klar Ernst, Schmitz Klaus-Peter, Kaule Sebastian
Format:	Article
Language:	English
Published:	De Gruyter 2023-09-01
Subjects:	medical device regulation post-market clinical follow-up registries regulatory affairs
Online Access:	https://doi.org/10.1515/cdbme-2023-1122