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. Aptiv Solutions 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, we can serve as your FDA U.S. Agent. For clients based outside of Europe, we can help you to identify a European Authorized Representative.
Aptiv Solutions 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