MDCI Services
In today's global marketplace, the development and marketing of medical products is a highly regulated process with strict governmental requirements. Since 1980, Medical Device Consultants, Inc. (MDCI) has provided regulatory, clinical, and quality assurance consulting services to help medical device and in vitro diagnostic product manufacturers meet those requirements.
Our client engagements number in the thousands and represent almost every therapeutic area and medical device specialty area, for both U.S.-based and international clients. By leveraging MDCI's comprehensive knowledge of FDA and international regulations, you can capture and grow market share, increase productivity, and stay competitive in an increasingly complex global marketplace.
Whether you need to define your regulatory pathway, support your product with a well-designed clinical trial, prepare your team for an FDA or ISO audit, or ensure ongoing compliance, MDCI has the experience and knowledge to lead you to success.
"Courage is fear holding on a minute longer."
George Patton
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 just wanted to write to thank you for a very thorough and “reviewer-friendly” response submission.
- Reviewer, FDA, Center for Devices and Radiological Health