In 2016, the latest edition of ISO 13485 standard for the Medical Device Industry was published by ISO.  The new 13485:2016 has some significant changes and any organization with a certification needs to understand the impact for an easy transition.

This course covers the changes on a clause-by-clause basis.

Because it covers Objective Evidence - it is a very useful course for ISO 13485 Internal Auditors.


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ISO 13485 Lessons