Join this live webinar on December 16, 2025 · 1:00–2:00 p.m. ET for an overview of the recently finalized Quality Management System Regulation (QMSR), the updated regulatory framework that will replace the current Quality System Regulation (QSR) under 21 C.F.R. Part 820. The FDA will walk through the key changes, how the QMSR aligns U.S. device quality-management requirements with the internationally recognized ISO 13485:2016 standard, and what this means for manufacturers — including impacts on inspection, compliance, labeling/packaging, and risk-management practices. Attendees will also have the opportunity to hear answers to frequently asked questions from FDA experts.