Date : Aug 8,2025
Time: 1PM -2:30 PM ET
Duration: 90 Mins
The FDA has officially replaced its long-standing Quality System Regulation (QSR) with the new Quality Management System Regulation (QMSR) — a major shift aligning U.S. medical device requirements with ISO 13485:2016.
This landmark update impacts device manufacturers, importers, and other stakeholders across the industry — and demands swift, strategic action.
In this practical, expert-led webinar, you’ll gain a clear understanding of what’s changed, what’s required, and how your organization can stay fully compliant.
What You’ll Learn:
1. Key differences between QSR and QMSR
2. How QMSR integrates with ISO 13485:2016
3. What documents and systems need to be updated
4. Practical steps for compliance readiness
5. Common pitfalls and how to avoid them
6. QMSR timelines and enforcement outlook
Whether you're a regulatory professional, quality manager, or executive responsible for compliance, this session will equip you with actionable insights to navigate the QMSR transition confidently.
Who Should Attend:
1. Quality & Regulatory Affairs professionals
2. Medical device manufacturers
3. Consultants and QA auditors
4. RA/QA teams preparing for FDA inspections
5. Anyone impacted by U.S. device compliance changes
Don’t wait to react — prepare to lead.
Register now and stay ahead of the curve in 2025.
