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.