Principal Consultant, H&M Consulting Group, LLC
Mark Swanson (ASQ CMQ/OE, CQE, CBA) is the President and lead consultant of H&M Consulting Group, a group focussing on helping small to mid-sized companies having the same regulatory and quality systems knowledge as the large medical device companies. In addition to this, Mark is also the Director of the Medical Technology Quality Graduate program at St. Cloud State University.
Mark has spent the last three years as an active member of ISO Technical Committee 210 (TC210), Working Group 1 (WG1) working on the revision of ISO 13485:2003 and has also participated with ISO TC176, WG24 on the next version of ISO 9001. 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 the different management system standards and other regulations into a single quality management system.
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ISO 14971-Incorporating Risk Management throughout the Product Life-cycle
A key process for all medical device companies is product risk management. While this webinar focuses on the application of risk management to product outlined in ISO 14971:2007, we will also discuss the risk-based approach outlined in ISO 13485:2016.
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