I3CGlobal is the ONLY consulting company who takes up complete turnkey FDA 510(k) projects. We cover any type of medical devices anywhere in the world FDA 510k .
Special features of I3CGlobal
- We will not assist, we prepare 510k!!!
- We provide service of US Agent!!!
- Initial in-depth study of product and regulatory followed by overall guidance
- Development of a Project Plan and confirmation of the specific deliverables.
- Guidance on testing
- Communicate to FDA regarding review comments
- Support in implementing 21 CFR 820
- Establishment registration
- Listing of products with US FDA
- Payment after completing every phase.