"Thank you so much for suggesting that I attend the ISO 13485:206 Training session today. You did a great job of explaining the intent behind the changes as well as providing tips on complying with the changes. Thanks again!"


This session was presented by R&Q Director of Minnesota Operations / Principal Consultant - and ISO Technical Committee 210 (TC210) and Working Group 1 (WG1) member - Mark Swanson.

This webinar outlines how organizations should establish a risk-based approach as outlined in the requirements of ISO 13485:2016, and the changes associated with implementation of the new edition of ISO 13485. In this session, we established a basic understanding of the application of the risk-based approach in your QMS process, the evidence that will show this implementation to auditors, and how these are implemented in your update to your QMS.

This session is perfect for:

  • Design Quality Engineers
  • Development Engineers
  • Risk Management Specialists
  • Regulatory Specialist
  • Quality Managers
  • Regulatory Affairs Managers
  • Quality Engineers
  • Manufacturing Engineers
  • Engineering Managers