October 2020
Intermediate to advanced
286 pages
7h 18m
German
book
Basiswissen Medizinische Software, 3rd Edition
by Christian Johner, Matthias Hölzer-Klüpfel, Sven Wittorf
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Vorwort zur 3. Auflage
Die Welt des Medizinprodukterechts dreht sich weiterhin schnell: Die EU-Medizinprodukteverordnungen (MDR und IVDR) haben die EU-Richtlinien weitestgehend abgelöst. Für die Hersteller bedeutet(e) dieser Umstieg eine hohe Belastung, zumal sich die Anzahl der benannten Stellen mehr als halbiert und damit die Verfügbarkeit benannter Stellen stark beeinträchtigt hat.
Für die Firmen und deren Mitarbeitende bleibt es herausfordernd, mit den Interpretationen der neuen Verordnungen, mit den Updates der Normen (z.B. zu den Software-Lebenszyklus-Prozessen und zur Gebrauchstauglichkeit), mit den neuen EU-Leitlinien sowie den Common Specifications Schritt zu halten.
Gleichzeitig nimmt der internationale Wettbewerb zu, neue Themen wie ...
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O’Reilly covers everything we've got, with content to help us build a world-class technology community, upgrade the capabilities and competencies of our teams, and improve overall team performance as well as their engagement.Julian F.
I wanted to learn C and C++, but it didn't click for me until I picked up an O'Reilly book. When I went on the O’Reilly platform, I was astonished to find all the books there, plus live events and sandboxes so you could play around with the technology.Addison B.
I’ve been on the O’Reilly platform for more than eight years. I use a couple of learning platforms, but I'm on O'Reilly more than anybody else. When you're there, you start learning. I'm never disappointed.Amir M.
I'm always learning. So when I got on to O'Reilly, I was like a kid in a candy store. There are playlists. There are answers. There's on-demand training. It's worth its weight in gold, in terms of what it allows me to do.