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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Autores principales: | Schmidt Wolfram, Brandt-Wunderlich Christoph, Stiehm Michael, Kaule Sebastian, Siewert Stefan, Bock Andrea, Schmitz Klaus-Peter, Kurzhals Anja, Grabow Niels |
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Formato: | article |
Lenguaje: | EN |
Publicado: |
De Gruyter
2020
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Materias: | |
Acceso en línea: | https://doaj.org/article/2d651749bcc14baa951977ac16ec5674 |
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