From QSR to QMSR: What Changed, What Didn’t, and What to Do Next | February 2026 Updates скачать в хорошем качестве

From QSR to QMSR: What Changed, What Didn’t, and What to Do Next | February 2026 Updates

With the FDA’s Quality Management System Regulation (QMSR) taking effect on February 2, 2026, medical device manufacturers need to be ready for an inspection model that aligns 21 CFR 820 to ISO 13485:2016 by reference, with a handful of U.S.-specific additions. In the video above, Tarja is joined by Mahshid Zahed (VP of Quality) and Elizabeth “Beth” George (Senior Regulatory Affairs Consultant) to break down what this shift really means in practice, including how the conversation is moving from “paper procedures” to implemented evidence, organized around the Medical Device File (MDF). What you’ll walk away with: What QMSR is, why FDA made the change, and what “harmonization” looks like day to day How to apply a true risk-based approach across the total product lifecycle, not just design and development Practical next steps: train teams, run a gap assessment, integrate ISO 14971 thinking, and prepare for inspection readiness Learn more at https://actionforresults.com/