Now it's time for the approvals for your new product. You'll have to meet specific criteria set forth by all of the appropriate regulatory bodies and be able to preserve the integrity of your manufacturing process as you scale up for production. You'll submit documents and your facilities will be audited by regulatory bodies. With us, you'll be prepared.
We can help you prepare and submit regulatory documents such as:
- Premarket notifications [510(k)s] (traditional, special, abbreviated)
- Premarket approval (PMA) applications, amendments and supplements
- Design Dossiers and Technical Files
- Manufacturing and software information for FDA
- Technical file preparation for CE Marking
- Device reclassification petitions
- Master files
- Canadian Device License applications
We can also help you prepare for FDA inspections and registrar or Notified Body assessments. In addition, we prepare statistical analyses and clinical reports.
If you are not based in the United States, MDCI can represent you as your U. S. Agent. And, if you're doing business in Europe, MDCI can serve as your European Authorized Representative.
Speak with a Consultant
Reach our Massachusetts office at 1-508-643-0434, Monday through Friday, 9:00 a.m. to 5:00 p.m. Eastern. Or click here and a consultant will contact you directly.
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