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...
Main Authors: | Schmidt Wolfram, Brandt-Wunderlich Christoph, Stiehm Michael, Kaule Sebastian, Siewert Stefan, Bock Andrea, Schmitz Klaus-Peter, Kurzhals Anja, Grabow Niels |
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Format: | Article |
Language: | English |
Published: |
De Gruyter
2020-09-01
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Series: | Current Directions in Biomedical Engineering |
Subjects: | |
Online Access: | https://doi.org/10.1515/cdbme-2020-3085 |
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