Innovators Circle: Risk Management

March 10, 2026 | Virtual | 3:00 – 4:00 PM ET | MDIC Members Only
This session will feature a focused and interactive discussion centered on Medical Device Single Audit Program (MDSAP) considerations, led by Edwin Bills.

During this session, Edwin will highlight “hidden” aspects of MDSAP that organizations should be aware of as they prepare for or undergo audits. The discussion will take a global approach and will explore where and how 21 CFR 820 continues to be referenced throughout MDSAP. Participants will also gain insight into the evolving MDSAP audit approach and what these changes may mean for manufacturers navigating today’s regulatory environment.

Following the presentation, we will facilitate an open discussion to explore how these considerations intersect with organizations’ early experiences implementing the February 2026 Quality Management System Regulation (QMSR). This will provide an opportunity for participants to share perspectives, ask questions, and discuss practical implications for risk management and global compliance strategies.