Quality Management System Regulation (QMSR): Key insights and strategies to prepare for the transition
From Feb 2026, FDA Part 820 aligns with ISO 13485.
Are you ready?
Join our session with Jennifer Mascioli-Tudor to learn what’s changing and how to prepare.
The FDA is making a significant quality shift.
On February 2 2026, the new Quality Management System Regulation (21 CFR Part 820) will replace the current rule, aligning US requirements with ISO 13485:2016. This will impact how medical device teams plan inspections and manage risk.
If you’re unsure about what changes are required, or how much restructuring is needed in your QMS, this upcoming session is for you.
You’ll walk away ready to:
- Understand what the FDA actually expects under QMSR and how it differs from today’s Part 820 requirements.
- Navigate new expectations around Risk Management and Management Review (QMR).
- Build a practical transition strategy so your organization is QMSR-ready and inspection-ready, long before 2026.
You’ll hear from Jennifer Mascioli-Tudor, Founder and CEO at JMT Compliance Consulting. And Angel Buendía, Scilife’s Knowledge Manager, will be moderating this online session.
📅 November 4th, 2025 | 4:00PM (CET)
Ditch the uncertainty. Transition to FDA’s QMSR with confidence and clarity.