What The Godfather Can Teach Us About Risk-Based Thinking
Date: Wednesday, September 30, 2026
Time: 1:00 PM – 4:00 PM ET
Cost: $49
Speakers: Mark Swanson & Steve Gompertz, QRx Partners
Registration: $49
Register here:
https://app.memberplanet.com/#/event/asqbiomedicaldivisioncommittee/riskythinkingitsnotpersonalitsbusiness.whatthegodfathercanteachusaboutriskbasedthinking
Risk-based thinking is everywhere in the medical device QMS but are you actually using it to make better decisions?
This hands-on, practical workshop moves beyond the buzzwords to show how risk-based thinking can be applied to the real decisions quality and regulatory professionals face every day.
Through real-world examples, case studies, and exercises, Mark Swanson and Steve Gompertz will explore how risk-based thinking differs from product risk management, where it should influence QMS decisions, and how organizations can use it to prioritize resources, right-size controls, and focus improvement efforts where they matter most.
Participants will put these concepts to work across supplier management, CAPA, audits, document control, design and development, production, management review, and other key QMS processes.
Learning Objectives
By the end of this workshop, participants will be able to:
- Explain the difference between product risk management and risk-based thinking within a QMS.
- Identify where risk-based thinking should influence quality system decisions.
- Apply practical methods for prioritizing resources, controls, and improvement activities based on risk.
- Recognize opportunities to streamline QMS processes by applying controls proportional to risk—without creating unnecessary bureaucracy.
Meet the Speakers
Mark Swanson, MBA, ASQ CMQ/OE, CQE, CMDA
Partner, QRx Partners
Mark Swanson is a Founding Partner of Quality and Regulatory Expert Partners, LLC (QRx Partners) and has more than 23 years of experience in the medical device industry across quality and regulatory roles. He has been actively involved in the development and implementation of international quality and risk management standards, including work with ISO TC 210 on ISO 13485 and post-market surveillance, ISO TC 176 on ISO 9001, and U.S. activities related to ISO 14971 and FDA's Quality Management System Regulation (QMSR). His work focuses on helping organizations effectively integrate regulatory and quality requirements into practical management systems.
Steve Gompertz, CMQ/OE, CMDA, RAC-US, CMII
Partner, QRx Partners
Steve Gompertz is a quality systems leader with more than 30 years of experience in the medical technology industry. His background spans quality systems development and implementation, project management, engineering automation, configuration management, auditing, and software development. His industry experience includes roles with organizations such as St. Jude Medical, Boston Scientific, Medtronic, and others. Steve is also a Senior Adjunct Instructor in St. Cloud State University's M.S. in Medical Technology Quality program and a Distinguished Speaker with the Society for Quality Assurance.
Why Attend?
Risk-based thinking should help organizations make smarter decisions—not simply add another layer of documentation. This workshop is designed to provide practical approaches you can bring back to your organization to build a more focused, efficient, and effective QMS.