Issues Driving the ISO 13485:2016 Revision
Standards are not revised in a vacuum. Industry changes, regulatory challenges, and feedback from medical device manufacturers, regulators, and auditors are all considered. In this two-part series, we discuss key changes to ISO 13485:2016 with Ed Kimmelman, an Oriel STAT A MATRIX Executive Management Consultant who recently retired as the Convenor of the ISO/TC 210, Working Group 1 on quality systems – the ISO working group responsible for developing ISO 13485:2016. For ISO 13485:2016, there were several issues that led […]
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