Medical Device Regulatory Clearance / Approval
In order to gain medical device regulatory clearance or approval, you will need to meet specific criteria set forth by all of the appropriate regulatory bodies. You will also need to preserve the integrity of your manufacturing process as you scale up for production. MDCI can prepare you and your facilities for possible regulatory audits, including FDA inspections and registrar or Notified Body assessments.
For clients based outside the United States seeking medical device regulatory approval, MDCI can serve as your FDA U.S. Agent. For clients based outside of Europe, MDCI can service as your European Authorized Representative.
MDCI will help you to write, assemble, and submit effective medical device regulatory documents, including:
- 510(k) Premarket Notifications (traditional, special, abbreviated)
- Premarket approval (PMA) applications, amendments and supplements
- Design Dossiers and Technical Files for CE Marking
- Manufacturing and software information for FDA
- Device reclassification petitions
- Master files
- Canadian Device License applications
- Establishment Registration
- Device Listings
Contact us to learn more about our medical device regulatory approval 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 look forward to working with you to complete the entire process and to celebrate the ultimate success of achieving FDA 510(k) clearance. I cannot think of better partners or a better team to achieve this final result!
- U.S. manufacturer and developer of a dental device