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. MDCI 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

Contact us today to learn more about our QA and Compliance Services.

Contact Us

Reach our Massachusetts office at 1-508-643-0434, Monday through Friday, 9:00 a.m. to 5:00 p.m. Eastern. Or fill out our contact form and a consultant will contact you directly.

Client Testimonial

I must admit, the FDA’s application process seemed daunting until MDCI provided a step-by-step process for gathering and producing the correct information.

- U.S. based manufacturer and developer of vascular imaging devices