FREE ON DEMAND WEBINAR

Countdown to QMSR: What you need to know to be ready for February 2026

The FDA’s Quality Management System Regulation (QMSR) will replace 21 CFR Part 820, with full enforcement beginning in February 2026. This sweeping change brings U.S. requirements into alignment with ISO 13485 and reshapes how medical device companies must prepare for inspections and compliance.

In this webinar, Eric Henry, a 35-year industry veteran and regulatory advisor, will share what manufacturers need to know to stay ahead of the deadline and inspection-ready.

Key learnings:

• Walkthrough of QMSR changes to 21 CFR Part 820
• The elements of a QMSR remediation program
• Prepare for FDA inspections under QMSR, including new focus areas
• Understand the end of QSIT and the rise of the Compliance Program Guide
• Anticipate how FDA investigators are being trained for QMSR enforcement