One of the most significant regulatory shifts in the U.S. medical device industry is here—are you ready for it?
With the FDA officially replacing the Quality System Regulation (QSR) with the Quality Management System Regulation (QMSR), organizations have a limited window to prepare for full compliance by February 2026. This session is your essential guide to understanding the why, what, how, and when behind this change—and how to turn it into a strategic advantage.
Whether you're a regulatory, quality, or compliance professional, this session will walk you through the rationale for this global alignment with ISO 13485, the key changes introduced, and what they really mean for your day-to-day operations. We’ll explore practical strategies to implement these changes, avoid costly pitfalls, and stay on track with the FDA’s transition timeline.
Expect interactive discussions, hands-on activities to compare QSR vs. QMSR, and real-world scenarios to help you assess your organization’s readiness. You’ll leave with clarity, confidence, and a clear action plan—not just to comply, but to leverage QMSR as a launchpad for stronger global market access and long-term quality success.
Learning Objectives:
Understand the rationale behind the FDA’s shift from QSR to QMSR.
Summarize key changes and how they align with ISO 13485.
Recognize risks of non-compliance and use QMSR as a springboard for global market access.
.jpg "Nivedha Subramanian, MS, RCC-MDR photo")
.jpg "Charles Nnabuife, BPharm, MBA, PMP, RAC photo")