book
Basiswissen Medizinische Software, 3rd Edition
by Christian Johner, Matthias Hölzer-Klüpfel, Sven Wittorf
October 2020
Intermediate to advanced
286 pages
7h 18m
German
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Inhaltsverzeichnis
1.2Initiative »Certified Professional for Medical Software« (CPMS)
1.3Zuordnung der Kapitel dieses Buches zum Curriculum des CPMS
2.1.1Das sogenannte neue Konzept für Produktregulierung innerhalb der Europäischen Union
2.1.2Regulatorische Landkarte für Medizinprodukte
2.2Regulatorische Vorgaben für Medizinprodukte
2.2.1Die Medizinprodukterichtlinie und die Medizinprodukteverordnung
2.2.2Besonderheiten für aktive implantierbare medizinische Geräte
2.2.3Besonderheiten für In-vitro-Diagnostika
2.2.4Die Gesetzgebung in der Bundesrepublik Deutschland
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