FDA Quality System Regulation (QSR)
In order to ensure that medical devices sold in the U.S. market are safe and effective, the FDA requires that manufacturers follow Good Manufacturing Practices (GMPs) as part of its Quality System Regulation (QSR: 21 CFR 820). Domestic and foreign manufacturers of medical devices must put in place a quality system that addresses the design, manufacture, packaging, labeling, storage, installation, and servicing of finished medical devices sold in the United States. Aptiv Solutions has designed and implemented quality systems for large and small medical device manufacturers; each is customized to best serve the client’s unique business requirements.
We will assist you with all aspects of your quality system requirements, including:
- Complaint Handling and Corrective and Preventive Action (CAPA) programs
- Design control, including risk management and design validation
- Document control systems
- Software quality assurance programs
- Process validation