Skip to main content
RAPS Euro Convergence 2026 Main banner
Icon Legend
This session is not in your schedule.
This session is in your schedule. Click again to remove it.
Presentation Icons
Learning Level: Advanced
Learning Level: Advanced
Learning Level: Expert
Learning Level: Expert
Learning Level: Foundational
Learning Level: Foundational
Learning Level: Intermediate
Learning Level: Intermediate
RAPS Focus
RAPS Focus
Networking Opportunity
Networking Opportunity
Ticketed Event
Ticketed Event
Student Focus
Student Focus
ViewAttendees 5

Medical Devices

QMSR: Navigating the New FDA Quality Management System Regulation (QMSR): Regulatory Insights and Compliance Strategies

Wednesday, May 6, 2026
08:30 - 09:30 WEST
Location: Auditorium 3
Learning Level: Intermediate
Description: Participants attending this session will gain a comprehensive understanding of the FDA’s new Quality Management System Regulation (QMSR) and its implications for regulatory compliance within the medical device industry. The session will clarify the alignment between the FDA’s QMSR and ISO 13485:2016, helping regulatory professionals grasp the nuances where FDA expectations may exceed international standards.

Attendees will learn how to identify and address key challenges associated with the transition from the legacy Quality System Regulation to the QMSR, including areas such as risk management integration, supplier controls, management accountability, and documentation requirements. This knowledge will enable participants to conduct effective gap assessments and develop targeted transition strategies that align with regulatory expectations, reducing compliance risks and preparing their organizations for successful FDA inspections.

Overall, this session offers valuable regulatory insights and practical tools, empowering participants to lead their organizations confidently through the QMSR transition while enhancing quality management effectiveness and regulatory readiness.

Learning Objectives:

  • Upon completion, participants will understand the key differences and similarities between the FDA’s new Quality Management System Regulation (QMSR) and the legacy Quality System Regulation, including alignment with ISO 13485:2016.
  • Upon completion, participants will be able to identify critical regulatory focus areas under the QMSR, such as risk management integration, supplier oversight, management responsibility, and documentation practices, to enhance inspection preparedness.
  • Upon completion, participants will be able to develop practical strategies for conducting gap assessments, planning the transition, and collaborating with cross-functional teams to ensure effective compliance with the new regulatory requirements.