Join Hogan Lovells to learn how FDA shifts will impact the medical device regulatory landscape.
Presented by Hogan Lovells
QMSR Transition: Legal and Audit Perspectives
December 9, 2025
11:00 AM – 12:00 PM
QMSR Transition: Legal and Audit Perspectives
December 9, 2025
11:00 AM – 12:00 PM
Join Hogan Lovells in their discussion of how the U.S. Food and Drug Administration (FDA) is set to dramatically reshape the medical device regulatory landscape with the introduction of the Quality Management System Regulation (QMSR), effectively replacing the long-standing Quality System Regulation (QSR) (21 CFR Part 820). This pivotal change mandates that manufacturers align their quality systems with the international standard ISO 13485:2016.
This essential webinar provides a comprehensive roadmap for medical device manufacturers to successfully transition to the new QMSR. We will clarify the scope and intent of the new rule, explore its strategic implications for global operations, and equip you with practical tools to ensure compliance.
Date: December 9, 2025
Time: 11:00 PM – 12:00 PM ET
Location: Online
RSVP now to stay ahead of the curve and uncover what’s next for MedTech in today’s dynamic healthcare landscape.
Meet The Speakers
Jodi Scott – Partner, Hogan Lovells
Jodi K. Scott is a nationally recognized FDA regulatory attorney known for guiding medical device and digital health companies through complex compliance challenges and regulatory crises. With prior experience as in-house FDA counsel at Medtronic PLC, the world’s largest medical device manufacturer, Jodi brings unmatched insight and a pragmatic approach to solving high-stakes FDA issues.
Mike Heyl – Partner, Hogan Lovells
Mike Heyl helps medical device companies navigate myriad regulatory and business matters. He guides clients through U.S. Food and Drug Administration (FDA) regulations, requirements, and compliance issues. These issues include FDA’s Quality System Regulation (QSR); adverse event reporting; recall reporting requirements; FDA inspections and enforcement actions, such as Warning Letters; defense strategies; and corrective and remedial action plans.
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