This half-day workshop provides a practical, implementation-focused introduction to the FDA’s guidance on computer software assurance and how it can be applied within a regulated quality system. Participants will explore how the guidance shifts the emphasis from exhaustive documentation toward risk-based, critical-thinking approaches that focus assurance activities where software failures could impact patient safety or product quality.
Through real-world examples and interactive discussion, the workshop will clarify how to define intended use, assess software risk, and select appropriate assurance activities aligned with FDA expectations.
Common misconceptions, including how the guidance applies to off-the-shelf software, spreadsheets, and configurable systems, will be addressed. Attendees will leave with a clear framework for tailoring software assurance activities that are both compliant and efficient, while supporting innovation rather than constraining it.
Venue: Hybrid
Onsite: St. Cloud State, 9750 Rockford Rd #100, Plymouth, MN 55442
Zoom: Zoom Link will be provided closer to the event date.
Date: Wednesday, August 5, 2026
Time: 10:00 am – 2:00 pm CST
Cost:
ASQ Members $60
Non-Members $80
Groups of 5 or More $60
Students $25 with an active school email. This email will receive all event communications.
THE EMAIL USED DURING REGISTRATION IS THE EMAIL USED FOR ALL EVENT COMMUNICATION, INCLUDING THE ZOOM LINK.
Certificates of Completion: Issued via email, after event completion, for .4 ASQ RUs or .4 CEUs
Questions: Please contact Karen Peifer, Committee Chair, at asqmnbmc@gmail.com
Use the MORE INFORMATION link below for registration information.
Your Speaker
Steve Gompertz,
Steve Gompertz (CQM, CBA, RAC-US, CMII) is a leader in Quality Systems management with over 30 years of experience in the medical technology industry. His career includes roles in quality systems development and implementation, project management, engineering automation, configuration management, audit, and software development for companies including Pelican BioThermal, St. Jude Medical (now Abbott), Boston Scientific, Medtronic, Vital Images, and Control Data. He is now a consultant to the industry providing guidance on quality systems and regulatory compliance. Steve holds a B.S. in Mechanical Engineering from Lehigh University, and certifications in quality management, medical device auditing, regulatory affairs, project management, and configuration management. Steve started his professional career in software development and then moved into systems implementation project management. After joining the medical device industry, he transitioned from implementing quality-related IT solutions to managing quality organizations and processes. Steve also helped St. Cloud State University develop and is a Sr. Adjunct Instructor in the “M.S. in Medical Technology Quality” program. Steve can be reached at Steve.Gompertz@QrxPartners.com, and more information about his experience is available at https://www.linkedin.com/in/stevegompertz/
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.
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To become a member of the MN ASQ Biomedical Consortium, please contact Karen Peifer, Committee Chair or Sahi Datla, Committee Co-Chair, at asqmnbmc@gmail.com.
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.
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