"It was a very well broken down and presented training. It was easy to follow along."

"Best aspect of webinar was in differentiation between product risk management (as part of design controls) and risk-based approach to QMS processes - very helpful."

"Mark did a fantastic job with this."

"It was great!"


Risk Considerations and Implementation of a Risk-based Approach 

Risk considerations and implementation of a risk-based approach in your QMS processes is one of the most significant changes to the current version of ISO 13485. Medical device organizations must define how they manage risk in their processes and how the risk of one process affects other risk aspects of the QMS. The concepts of risk management are not new. In previous editions of ISO 13485, risk management primarily focused on product risk using design risk. ISO 13485:2016 places greater emphasis on the inclusion of risk management throughout the QMS and the use of feedback for improvement.

This webinar will explain the concept of risk-based approach in ISO 13485:2016, establishing processes that incorporate the risk-based approach, determining acceptable residual risks, the use of feedback and overall conformity of your QMS.

What you will learn

  • What is risk-based approach
  • Where is risk addressed in ISO 13485:2016
  • Why use a risk-based approach
  • How do you use a risk-based approach
  • What to show as evidence of conformity for the implementation of a risk-based approach


About the med device expert

Mark Swanson, mark_swanson_headshot_square.jpgExecutive Director, Intelligence & Technical Excellence

Mark is R&Q's Director of Minnesota Operations / Principal Consultant - and is also a member of ISO Technical Committee 210 (TC210) and Working Group 1 (WG1). Additionally, he is a member of the MDIC Case for Quality Forum. Mark (CMQ/OE, CQE, CBA) has spent more than four years as an active member of ISO Technical Committee 210 (TC210), Working Group 1 (WG1) working on the revision of ISO 13485:2003 that was published on March 1, 2016 and has also participated with ISO TC176, WG24 on ISO 9001:2015. This work includes discussions regarding the impact of changes in the ISO quality management system standards, the integration of various standards and how to effectively integrate these various international standards and other regulations into a single quality management system.