U.S. Based Medical Device Firms
With over 8,000 firms, U.S. medical technology companies lead the world in medical device production. Many of these U.S. based firms also seek to expand their markets to become strong competitors globally. Some international regulatory barriers, however, especially those in developing economies, can be difficult to surmount. Medical device firms often devote tremendous amounts of time and money to determine requirements, conduct additional overseas clinical trials, and pay user fees.
While it is not possible to see products, "approved once and accepted everywhere," MDCI can help medical device firms to develop regulatory and clinical trial strategies that will most efficiently address requirements from a global perspective.
In addition to assisting clients with U.S. FDA regulatory, clinical trial, and quality assurance challenges, MDCI can guide clients through the complexities of obtaining the CE mark and serves as EU Authorized Representative for clients entering the European market. MDCI also helps clients to meet the requirements of Health Canada to enter the Canadian market.
Contact Us to learn more about our services for U.S. Based Medical Device Firms.
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.
Useful Links
For all areas of expertise, MDCI offers the following services:
Client Testimonial
The expertise and knowledge that MDCI shared truly helps us accomplish our mission of helping U.S. companies increase their export sales.
- International Trade Specialist at US Department of Commerce