Abstract
The FDA’s new Quality Management System Regulation (QMSR), taking effect in February 2026, represents the most significant shift in U.S. medical device quality requirements in decades. This webinar will provide a deep dive into how the QMSR differs from the legacy Quality System Regulation (QSR), with a clear breakdown of the structural, procedural, and documentation changes manufacturers should expect. We will explore how the QMSR aligns with ISO 13485:2016 and how this harmonization affects organizations operating in the U.S., EU, and other global markets. This session is designed to equip regulatory, quality, and compliance professionals with the knowledge needed to prepare confidently for the 2026 implementation.
You will gain insight into
FDA’s expectations for compliance - Practical strategies for transitioning existing quality systems
- Differences between the new QMSR vs QSR
- Real‑world impact on device development, manufacturing, and post‑market activities.
