QMSR Transition and ISO 13485:2016 Alignment

Expert Live Q&A for Medical Device Manufacturers  

With the February 2, 2026, release of the updated Quality Management System Regulation (QMSR), many medical device professionals are facing new uncertainties. How does QMSR align with ISO 13485:2016? What are the biggest changes? How should organizations adjust their quality systems to remain compliant?  

These changes introduce new expectations, terminology aligned with ISO 13485, and requirements affecting documentation, processes, and audits. If you're unsure how these updates impact your daily work, you’re not alone.  

That’s why this Live Q&A session was created to give you direct, practical answers from experts so you can confidently navigate the transition.  

Event Details:   

• 25 minutes: Addressing the most frequently asked QMSR questions  
• 15 minutes: Interactive live Q&A with attendees  

Why Attend?  

• Get clarity on the February 2026 QMSR update and its practical impact  
• Understand how the updated regulation aligns with ISO 13485  
• Learn what actions you should take to prepare  
• Ask your specific questions directly to experts  

Speaker:  

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.  

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.