Standardization of in vitro testing for cardiovascular implants in the era of European Medical Device Regulation

Standardization of in vitro testing for cardiovascular implants in the era of European Medical Device Regulation

In case of cardiovascular implants classified as class III medical products there is a specific responsibility for manufacturers as well as regulatory authorities to follow international standards to guarantee for safety and efficacy. Fast developments of science and technology as well as novel clin...

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Bibliographic Details
Main Authors: Schmidt Wolfram, Brandt-Wunderlich Christoph, Stiehm Michael, Kaule Sebastian, Siewert Stefan, Bock Andrea, Schmitz Klaus-Peter, Kurzhals Anja, Grabow Niels
Format: Article
Language:English
Published: De Gruyter 2020-09-01
Series:Current Directions in Biomedical Engineering
Subjects:
vascular stents
artificial heart valves
in-vitro testing
standardization
medical device regulation
Online Access:https://doi.org/10.1515/cdbme-2020-3085

Internet

https://doi.org/10.1515/cdbme-2020-3085

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