WATCH NOW - Risk Management Changes in ISO 13485:2016

Risk management requirements for medical device manufacturers will expand significantly with the publication of ISO 13485:2016. Manufacturers will have to approach risk management controls in a new way, and change how they integrate it with their quality management system procedures.

In this recorded webinar we discuss risk management practices for global device manufacturers and how these rules will change.


  • High level summary of current medical device manufacturer risk management requirements
  • Common deficiencies in risk management processes
  • Types of risks applicable to medical device manufacturers beyond patient/user-device risks
  • Risk management and ISO 13485:2016
  • Considerations for ISO 13485:2016 risk management compliance

Recorded December 2016


Michael Dun (RAC) is the Country Manager/Director for Emergo Australia and a Senior RA/QA Consultant. He is an expert in medical devices and IVDs, and previously held senior device development roles and led risk management teams. He holds a bachelors (honours) degree in Biotechnology from Macquarie University in Sydney, Australia.