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Showing posts tagged with: medical device

Understanding Roles & Processes in ISO 13485:2016

Understanding Roles & Processes in ISO 13485:2016

What is a role and how does it connect to processes?   The 2016 edition is much more complicated than the 2003 edition so here is a little help to make things a little more understandable. In ISO 13485:2016 there are many new terms, definitions, and requirements compared with the 2003 edition. "First, a stab of the ISO bureaucrats…...
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