Die Pathologie im Rahmen des europäischen und nationalen Medizinprodukterechts: Betrieb, Anwendung und Eigenherstellung von In-vitro-Diagnostika

Die Pathologie im Rahmen des europäischen und nationalen Medizinprodukterechts: Betrieb, Anwendung und Eigenherstellung von In-vitro-Diagnostika

Institutes for pathology act as operators, users and in-house manufacturers of in vitro diagnostic medical devices and are subject to national and European regulations depending on their function. The entry into force of the EU regulation on medical devices (Regulation (EU) 2017/745, MDR) and the EU...

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Bibliographic Details
Main Authors: Kahles, Andy, Goldschmid, Hannah, Volckmar, Anna-Lena, Kazdal, Daniel, Gassner, Ulrich M., Vogeser, Michael, Brüggemann, Monika, Bürrig, Karl-Friedrich, Kääb-Sanyal, Vanessa, Flechtenmacher, Christa, Schirmacher, Peter, Stenzinger, Albrecht
Format: Article
Language:deu
Published: German Medical Science GMS Publishing House 2024-10-01
Series:GMS German Medical Science
Subjects:
ivdr
quality management
legislation
regulatory requirements
laws and regulations
in vitro diagnostic medical devices (ivd)
Online Access:http://www.egms.de/static/en/journals/gms/2024-22/000335.shtml

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http://www.egms.de/static/en/journals/gms/2024-22/000335.shtml

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