QMSR Awareness Training: Transition to FDA aligned with ISO 13485
Duration: 1/2 day (Approximately 4 hours)

This half-day course helps U.S. medical device manufacturers understand and prepare for the FDA’s new Quality Management System Regulation (QMSR), effective February 2, 2026. QMSR aligns 21 CFR Part 820 with ISO 13485:2016, and this training covers the key changes, FDA-specific expectations, and strategic steps for compliance.

Learning Objectives:
- Explain the scope and purpose of the FDA’s QMSR update.
- Compare the previous QSR (21 CFR Part 820) with ISO 13485:2016.
- Identify FDA-specific compliance expectations under QMSR.
- Describe the implications for U.S. manufacturers in terms of inspections and records.
- Outline steps to prepare an organization for the QMSR transition by February 2026.
- Examine the Auditor's perspective of key areas of focus during QMSR inspections

Target Audience: U.S.-based medical device manufacturers, regulatory and QA personnel unfamiliar with QMSR or ISO 13485.

There are no prerequisites for this course, however, we recommend a basic awareness of ISO 13485 or FDA QSR (21 CFR Part 820).