Webinar Details:

The FDA’s transition from the Quality System Regulation (21 CFR 820) to the Quality Management System Regulation (QMSR) aligns US medical device regulations with ISO 13485:2016. As a result, the medical device industry is now required to follow standards that were previously voluntary. The QMSR has been in effect since February 2, 2026, and FDA inspectors are applying it now. Audit patterns are consistent: quality systems built for QSR compliance are not ready for QMSR scrutiny. There are several high-impact areas that manufacturers often underestimate during the transition from QSR to QMSR. These include integrating risk management throughout the device lifecycle, adopting a new risk-based approach to supplier management, and placing greater emphasis on integrating risk management across design phases.

This 90-minute webinar provides medical device quality professionals and executives with actionable strategies to successfully navigate the new inspection paradigm, mitigate compliance risks, and leverage the transition to drive operational excellence.

Training Program Learning Benefits:

• Explain the FDA’s transition from QSR to QMSR.
• Identify the key differences between the QSR and the QMSR: incorporation of ISO 13485:2016 by reference
• Understand the role of documentation in the QMSR
• Apply strategies for achieving QMSR readiness: gap assessment, remediation planning, and employee training.
• Leveraging Risk Tools to target high-risk areas
• What to expect when the investigator arrives
• Managing FDA observations

The following should plan to attend:

• Quality Assurance
• Quality Control
• Research & Development
• Regulatory Affairs
• Manufacturing
• Executive management
• Those who use contract manufacturing and contract testing facilities
• Those who work in the Regenerative Medicine space with products that are classified as medical devices

Fee:
$385 for one person
$700 2-5 people
$999 6-10 people

Register for ECC-774