Programs & Events

ISO 13485 Is Changing: How, Why and When?

St. Cloud State Series


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Registration: 7:30 am - 8:00 am
Program: 8:00 am - 11:30 am

Event Description

This program is at capacity and is closed for registration. We apologize for any inconvenience.

The revision of ISO 13485 continues to move forward, with the Committee Draft process heading toward registration of a new Draft International Standard. SCSU faculty members Scott Sardeson and Mark Swanson are members of ISO's TC210 working group, which meets again in early October. Join Scott, Mark, and fellow faculty member Steve Gompertz for a comprehensive look at ISO 13485 and work on the revision of related standards:
• How are ISO standards developed, and how do they figure into both quality and regulation?
• Why is 13485 changing?
• What will the changes be, and what is the proposed timing?
• What are the implications for other ISO standards and for the medical device industry?


Scott S. Sardeson, RAC-EU/US, International Regulatory Affairs Manager, 3M; Mark Swanson, Owner/Lead Consultant, H&M Consulting Group; Steve Gompertz, President, QMS Potential LLC

Scott S. Sardeson, RAC-EU/US He has held various positions at start-up and multinational medical device companies in manufacturing, research and development, quality, (more)

Mark Swanson is an experienced project leader and QA professional with significant medical device experience, including (more)

Steve Gompertz is a leader in Quality Systems management with over 20 years of experience in the medical device (more)


The following topics will be addressed:

  • Special Feature


St. Cloud State University
Twin Cities Graduate Center
6401 Sycamore Court N.
Maple Grove, MN 55369

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