ISO 13485:2016 Requirements for Quality Management Systems – Webcast Replay

Software Solutions for Medical Device Innovators

Are your products ISO 13485:2016 compliant?

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

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