In its place is an emphasis on meeting regulatory as well as customer requirements, risk management and maintaining effective processes, namely the processes specific to the safe design, manufacture and distribution of medical devices. ![]() ![]() The 2016 version of ISO 13485 removes 9001’s emphasis on continual improvement and customer satisfaction. Though based on ISO 9001, ISO 13485 does not fulfill the requirements of 9001. The current document supersedes its 1996 incarnation as well as EN 46001, EN 46002 and ISO 13488. ![]() ISO 13485:2016 represents the requirements that medical device manufacturers must incorporate into their management systems.
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