Advanced Module on the FDA’s New QMSR
The quality management system is the backbone of regulatory requirements for medical devices in the United States. With the new Quality Management System Regulation (QMSR), the FDA has fundamentally modernized thepreviousQuality System Regulation (QSR, 21 CFR 820) and brought it more into line with the international standard ISO 13485.
The goal of the QMSR is to achieve extensive harmonization of U.S. requirements with international quality management standards. For manufacturers, this means that existing QM systems must be reviewed, adapted, and strategically developed further.
In this seminar, you will learn about the structure, background, and key requirements of the new QMSR. You will discover whatchanges have been made compared to thepreviousQSR and what practical implications this has for your company.
In addition, you will receive an overview of the regulations thatremainin effect:
- 21 CFR 803 (Medical Device Reporting)
- 21 CFR 806 (Reports of Corrections and Removals)
In addition to the regulatory fundamentals, the focus is on practical implementation:
- How do you efficiently integrate the QMSR requirements into your existing QM system?
- What interfaces with ISO 13485 arise?
- What can you expect during an FDA inspection under the new framework?
- Content
- Overview of QMSR – Structure and Systematics
- Background of the Transition, Objectives of Harmonization, Integration of ISO 13485 into 21 CFR 820
- ISO 13485 in the FDA Context
- Direct References, Supplementary FDA-Specific Requirements, and Deviations
- 21 CFR 803: Medical Device Reporting (MDR)
- Reporting Requirements for Incidents and Serious Events
- 21 CFR 806: Reports of Corrections and Removals
- Requirements for Recalls, Corrective, and Preventive Actions
- Differences Between the Old QSR and the New QMSR
- What Specifically Changes for Manufacturers?
- FDA Inspections Under the QMSR
- Preparation, Process, and Successful Strategies for Audits
- Your Benefits
- You will understand the structure and framework of the new QMSR.
- You will understand the implications of harmonization with ISO 13485 for your quality management system.
- You will be able to confidently identify and implement FDA-specific additional requirements.
- You will know how to correctly fulfill reporting obligations under 21 CFR 803 and 806.
- You will be fully prepared for FDA inspections under the new regulations.
- Methods
Instructor-led sessions, group exercises, facilitated case studies, practical exercises, individual work, real-world case studies, discussions, live coaching, storytelling.
- Target Audience
- Quality management representatives and managers
- Regulatory affairs managers
- Medical device manufacturers and authorized representatives
- Employees in production, development, and compliance
- Service providers and consultants in the fields of quality management and FDA regulations
