June 2015
Intermediate to advanced
240 pages
6h 10m
German
book
Basiswissen Medizinische Software, 2nd Edition
by Christian Johner, Matthias Hölzer-Klüpfel, Sven Wittorf
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4 Risikomanagement
4.1 Einführung
Es liegt auf der Hand, dass die Risiken, die durch Medizingeräte für Patienten, Anwender oder Dritte entstehen, erkannt und minimiert werden müssen. Insofern verlangt die Medizinprodukterichtlinie (MDD) im Anhang I zu den grundlegenden Anforderungen zuerst, dass »die Produkte so ausgelegt und hergestellt sein müssen, dass ihre Anwendung weder den klinischen Zustand und die Sicherheit der Patienten noch die Sicherheit und die Gesundheit der Anwender oder gegebenenfalls Dritter gefährdet, [...], wobei etwaige Risiken verglichen mit der nützlichen Wirkung für den Patienten vertretbar und mit einem hohen Maß des Schutzes von Gesundheit und Sicherheit vereinbar sein müssen«.
Dies bedingt zum einen, dass man die Risiken ...
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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.