In this webcast, Robert Lesnefsky, Amir Pirastehfar, and David Wolf discuss the latest Quality Management System requirements for medical devices according to ISO 13485:2016. These requirements apply to organizations regardless of size or type with few exceptions.
In the discussion you will find out more about:
ISO 13485: The Overview
ISO 13485: The 2016 Major Changes
FDA Case for Quality Initiative
eQMS and Design Control Harmonization
Medical Device Audit Readiness Plan
Windchill Product Quality
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