Harmonization of QSR 21 CFR Part 820 with ISO 13485:2016

In a transformative step toward global regulatory alignment, the U.S. Food and Drug Administration (FDA) has finalized its rule to harmonize Title 21 of the Code of Federal Regulations Part 820 with the International Organization for Standardization 13485:2016 (21 CFR Part 820 with ISO 13485:2016), introducing new expectations around documentation, risk management, supplier controls and other aspects of Quality Management Systems (QMS) for medical devices.

While this promises simplification, smooth transitions demand careful attention to significant gaps and high-risk areas. This complimentary webinar explores the implications of the Final Rule on the Quality Management System Regulation (QMSR), highlights critical challenges, and offers practical guidance for achieving compliance by the 2026 deadline.

Who should attend

Learning objectives

• Understanding the key changes, who is impacted and how
• Get clear answers to frequently asked questions (FAQs) for existing and prospective manufacturers
• Identify high-risk areas and focus points for QMS impacted by this Final Rule

Don’t miss this important webinar. If you are unable to attend live, register anyway to watch on demand and share the link with your team.

Register now

Moderator:
James Stoia, senior product and service specialist, consumer electronics, medical, information technology, UL Solutions

Presenter:
Deborah Stubbs, principal engineer, consumer electronics, medical, information technology, UL Solutions