Prepare for QMSR: Step-by-Step Guidance for FDA’s ISO 13485 Alignment

The FDA’s long-anticipated Quality Management System Regulation (QMSR) goes into effect in February 2026, marking a major shift by aligning FDA requirements with ISO 13485. This update presents both challenges and opportunities to streamline your quality processes while meeting new compliance expectations.

In this webinar, Steve Keverline, Principal Advisor at RQM+, and Tom Rish, Senior Product Marketing Manager at Jama Software, break down key changes, share strategies for companies at all stages of ISO 13485 adoption, and provide actionable tools to help you prepare.

Whether you’re just beginning your QMSR journey or fine-tuning a mature system, this session will equip you with the clarity and direction needed for QMSR success.

Key Takeaways:

• What is QMSR, why is the FDA aligning with ISO 13485, and what does this mean for your business?
• The key elements of ISO 13485 that are critical to QMSR-readiness.
• Strategies for both early adopters and seasoned organizations adjusting to QMSR-specific requirements.
• Best practices to align design control and risk management activities.
• Step-by-step insights, including leveraging integrated software tools to enhance risk management and traceability.

Don’t wait for 2026. Start preparing now to reduce risk, increase efficiency, and confidently lead your team through this regulatory shift.