With FDA’s Quality Management System Regulation (QMSR) now in effect as of February 2, 2026, this webinar will give medical device manufacturers a clear, practical understanding of what the new rule requires and how to align their quality systems efficiently.

We will cover:

• What’s actually new in the QMSR: How FDA’s adoption of ISO 13485:2016 changes compliance expectations and what elements of the old QSR still apply.
• FDA inspection focus areas: What inspectors will look for under the QMSR and how to avoid common compliance gaps.
• Key gaps for ISO certified companies: Where ISO 13485 alone is not enough to satisfy FDA requirements.
• A practical transition roadmap: Actionable steps for updating procedures, training teams, and preparing for QMSR aligned inspections.