RA/QS Affinity Group Conference Call

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Tuesday, May 2, 2017
10:00 am – 11:00 am

Location: Online


  • Welcome
  • Regulatory Update - D. DiSabantino
  • Draft FDA Guidances Open for Comment - D. DiSabantino
  • Presentation: ISO 13485:2016: Incorporation of the Risk-based Approach - Presented by Mark Swanson, Director, Minnesota Operations, Regulatory and Quality Solutions (R&Q)

Description: The latest edition of ISO 13485 requires the risk-based approach in your QMS processes. This presentation will provide an overview of how this is best done and a couple of practical examples from one of the ISO working group members.

About the Presenter:

Mark’s career spans more than 17 years in medical device quality, quality management systems and regulatory compliance. Mark has recently joined Regulatory and Quality Solutions (R&Q) as the Director for Minnesota operations for regulatory and quality consulting in the medical device industry. Prior to this, he has been the President and lead consultant of H&M Consulting Group; a group focused on helping small to mid-sized companies have the same regulatory and quality systems knowledge and expertise as the large medical device companies. Mark has also had several different roles in medical device quality and regulatory compliance at Medtronic and St. Jude Medical. Mark is a Senior Member of ASQ and holds ASQ certifications as a Certified Biomedical Auditor (CBA), Certified Quality Engineer (CQE) and Certified Manager of Quality/Organizational Excellence (CMQ/OE).

  • MedTech Updates - Including MEDTECH 2017 and educational opportunities - K. Williamson

The RA/QS affinity group consists of regulatory and quality professionals focused on the quality principles and regulatory issues affecting today’s rapidly changing global medical device, pharmaceutical and biotechnology companies. In partnership with MedTech, RA/QS facilitates related networking and events through training, education and industry knowledge that help professionals advance themselves and their companies. RA/QS has quarterly calls that include an overview of regulatory updates and FDA draft guidances, as well as, a featured guest presentation.


  • Dominick DiSabatino, Associate, Loeb & Loeb

  • Paul Harger, Client Solutions Leader, Regulatory and Quality Solutions (R&Q)

Members only, please. 

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