Showing posts with label essential performance. Show all posts
Showing posts with label essential performance. Show all posts

Thursday, 21 January 2016

New Developments in IEC 60601 Amendment 1 & Risk Management: Part 2

Medical manufacturers live in a world where  regulatory compliance must always be considered,  including changes associated with IEC 60601. ...

Tuesday, 13 October 2015

How Scary are the Device Safety Requirements in IEC 60601-1 Edition 3.1?

 Yikes! Amendment 1 introduces over 20 new  requirements and 60 modifications. by Lisa Weeks,  Marketing Communications, MasterControl  ...
 

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