Common Sense Systems

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IEC 60601-1 Third Edition Compliance Management
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Author: Remya Krishnan

Publish Date: 2/20/2013

This Common Sense Systems whitepaper reviews the challenges facing medical device manufacturers by the third edition of IEC 60601-1 which, unlike its predecessor, requires documentation of risk management and essential performance throughout the product lifecycle.  Included is a case study of a project that Commons Sense facilitated through 60601-1 3rd edition compliance including processes that helped ensure rapid compliance and certification.