The FDA has finalized a significant update to its medical device quality system requirements by replacing the Quality System Regulation (QSR) with the Quality Management System Regulation (QMSR). This change aligns U.S. regulatory requirements more closely with international standards by incorporating ISO 13485:2016 by reference.

This webinar provides a structured overview of the QSR-to-QMSR transition, explaining the regulatory intent behind the change, the key differences between the two frameworks, and the potential compliance implications for medical device manufacturers.

Attendees will gain clarity on how the updated regulation may affect quality system elements such as documentation, risk management, supplier controls, and inspection readiness.

After this webinar attendees will be able to answer

• What is changing with the FDA’s transition from 21 CFR Part 820 (QSR) to the Quality Management System Regulation (QMSR)?
• How is ISO 13485:2016 incorporated into the new QMSR framework?
• Which areas of an existing quality system are most impacted by the QMSR update?
• How FDA’s regulatory expectations may differ under QMSR compared to the legacy QSR
• What internal reviews or assessments organizations should consider before QMSR enforcement

This webinar benefits the following agencies

• Medical device manufacturers
• Contract manufacturers and suppliers
• Quality assurance and quality management teams
• Regulatory affairs and compliance functions
• Organizations subject to FDA medical device inspections

Who should attend?

• Quality Assurance and Quality Management professionals
• Regulatory Affairs and Compliance personnel
• Engineering and Product Development teams
• Manufacturing and Operations management
• Risk Management and Supplier Quality professionals
• Consultants supporting FDA-regulated medical device companies