Medical Device Quality Assurance
Medical devices manufacturers who want to distribute their products in the United States, Canada, Europe, and around the globe are subject to a variety of Quality System regulations, intended to ensure the overall quality and safety of medical devices. Suppliers to the medical device industry, such as design firms and contract manufacturers, must also establish and maintain compliant quality systems in order to ensure that the services they provide meet the same quality requirements.
MDCI has worked with medical device and IVD manufacturers, and industry suppliers in the United States, Europe, Canada, and around the globe to implement and maintain compliant quality systems. Our consultants offer a broad range of expertise and have “hands on” experience with a wide variety of medical device products.
We will help you to prepare appropriate documents to bring your organization into compliance with the requirements of the FDA Quality System Regulation (FDA QSR) and ISO 13485:2003. In addition, we will provide training, assistance in implementation, and a final audit in preparation for all your required inspections.
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.
Device Regulatory Guidance
Click here to view FDA and International Regulatory Guidance for medical devices.
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