FDA's Part 820 Alignment with ISO:13485 A Risk Discussion with Mark Swanson

When:  Apr 4, 2024 from 05:30 PM to 07:00 PM (CT)
Associated with  Minnesota Section

Our first event was so popular, we've asked Mark to do it again.  The current version of ISO 13485 significantly increased the reference to risk within your QMS. This frightens many people and organizations as they struggle to answer auditor questions.

 Over the next two years, the US FDA will adopt ISO 13485 requirements by reference.  As an active participant in drafting these requirements, Mark provides a unique perspective on the intent of these requirements.  How to incorporate a risk-based approach to the requirements of the QMS, may be easier than you may think.

Who Should Attend: Engineers, Managers, and Team Members responsible for Quality, Reliability, Regulatory, Production, and Medical Device Development 

When: Thursday, April 4th, 5:30 pm - 7:00 PM CST

Where: Online Zoom Event.  A link will be provided closer to the event date


  • ASQ Members $25

  • Non-Members $35

  • Students $10 – Free when registering with school email and coupon code BMC1

  • Group registration of 5 or more receive Member pricing

Certificates of Completion: Issued via email, after workshop completion, for .2 ASQ RUs or .2 CEUs

If you have any questions, please contact Karen Peifer at kdpeifer@memberleader.asq.org

Mark Swanson, Partner, QRx Partners

(ASQ CMQ/OE, CQE, CBA) is the President and lead consultant of Quality and Regulatory Expert Partners, LLC (QRx)

QRx is a partnership focused on helping small to mid-sized companies have the same regulatory and quality systems knowledge as large medical device companies. Mark has more than 20 years of experience in the medical device industry including all roles in quality. He is a senior member of ASQ and RAPS as well as a corporate AAMI member (serving on several AAMI committees).

Mark has spent the last several years as an active member of ISO Technical Committee 210 (ISO TC210), Working Group 1 (WG1) working on the revision of ISO 13485 that was published in March 2016, was the project co-lead for the guidebook on ISO 13485 and lead US member of Working Group 6 (WG6) on post-market surveillance (ISO TR 20416). He has also participated with ISO TC176, WG24 on ISO 9000/9001:2015 and in the AAMI group responsible for TIR 102, to formally compare ISO 13485 to the US FDA Quality System Regulation. To add to this, Mark also participated in the US TAG for risk management (ISO 14971) and the workshop that created IWA 31 (agreement on the application of risk management in standards). In this work, he leads the 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 management system.

Sponsor Information

The MN ASQ Biomedical Consortium (BMC) is a group of quality professionals promoting and advancing quality tools, principles, and practices through educational events.  We focus on the medical device industry but promote events for other regulated environments.  As an active member, you can attend BMC events for free!

·         Follow us on LinkedIn to stay informed of upcoming events:  https://www.linkedin.com/showcase/90642322/

 To become a member of the MN ASQ Biomedical Consortium, please contact Karen Peifer at kdpeifer@memberleader.asq.org.

The American Society for Quality (ASQ), Medical Device Division (MDD) enables and elevates quality professionals in the medical device industry by providing thought leadership, education, collaboration networking, and leadership opportunities and by nurturing professional development. MDD is dedicated to elevating industry standards and driving continuous improvement to make a lasting impact on the medical device industry and the lives it touches.

Join our community or contact us for more information at: asqmddiv@divisions.asq.org

MN ASQ Programs Committee's goal is to connect quality personnel to discuss our day-to-day topics of our professional life, to create a network that support excellence through quality.

Join our community by contacting us for more information:  Bas Barath at bbarath@memberleader.asq.org or Mattheus Elisiario at melisiario@memberleader.asq.org.

The American Society for Quality (ASQ), is a knowledge-based global community of quality professionals, with nearly 80,000 members dedicated to promoting and advancing quality tools, principles, and practices in their workplaces and communities.  As your career partner, ASQ membership benefits are designed to help meet your growing needs as a quality professional.  Membership provides exclusive access to quality knowledge, solutions, and resources to solve challenges, and skill development to advance your career. ASQ is committed to providing enhanced expertise, professional networks, tools, and solutions to help our members advance their products, services, and industries.

ASQ:  https://www.asq.org/ 


Online Instructions:
Url: http://mp.gg/i93sxnfp
Login: A Zoom link will be provided closer to the event.