Countdown to February 2026: FDA’s New QMSR and ISO 13485 Alignment

On-Demand Webinar
Duration: 60 minutes 

Beginning February 2, 2026, all manufacturers seeking to market devices in the United States must comply with the FDA’s new Quality Management System Regulation (QMSR). This regulation replaces the longstanding Quality System Regulation (QSR) and incorporates ISO 13485:2016 by reference, creating stronger alignment with international quality management requirements. 

With QMSR’s alignment to ISO 13485:2016, manufacturers participating in the Medical Device Single Audit Program (MDSAP) will be well-positioned, as MDSAP audits are based on ISO 13485 and can support compliance across multiple markets, including the U.S. 

In this on-demand webinar, hosted by TÜV SÜD, our experts will provide an overview of the regulation, highlight the changes compared to the former QSR, and outline how manufacturers can prepare their QMS for this transition. 

We'll discuss: 

• Transition from QSR to QMSR: scope and changes 
• FDA’s incorporation of ISO 13485:2016 by reference 
• February 2026 compliance deadline – what manufacturers must prepare 
• The relationship between QMSR and MDSAP audits 
• Lessons learned from ISO 13485 implementation globally 
• The relationship between QMSR and MDSAP audits
• Lessons learned from ISO 13485 implementation globally

Join us live to gain a clear understanding of the new QMSR requirements and what steps your organization should prioritize ahead of the deadline. 

Meet the speakers 

Sofia Epshtein Elbrus
Expertise Manager, Technical Team 

Sofia serves as the TÜV SÜD Global MDSAP and (EN) ISO 13485/ISO 9001 Conformity Assessment Procedure Specialist (CAPS), as well as a Technical Department Manager with TÜV SÜD Americas.  Sofia’s background is in Physics and Industrial Engineering, and she has worked in Compliance Testing, Regulatory and Quality Management, and Corporate Auditing at various Medical Device Manufacturers before joining TÜV SÜD in April 2022 as Audit Department Manager. 

 

Dawn Tibodeau 
Global Regulatory Affairs Principal - MDSAP  

With over 20 years at TÜV SÜD, Dawn has held various key roles, including MDSAP Program Specialist and 510(k) 3rd Party Review Program Manager. Her experience and expertise make her an authority in medical device regulations and compliance. 

 

Disclaimer:  
This webinar is intended for general educational purposes only and does not provide product-specific guidance or regulatory guidance services. TÜV SÜD supports medical device manufacturers with accredited testing, certification, and auditing services to help demonstrate compliance with applicable requirements. Contact us to learn more.