To create this world class 510 (k), Class II application, we would offer a performance guarantee that defines what we do. This performance contract states our participation and the clearly limits of our obligations. We can only offer a fixed-fee and a schedule where we place boundaries on our obligations.


1. C² will create a regulatory strategy to achieve a regulatory decision.
2. C² will assist in shaping the product to fit through the review processes.
3. C² will research your regulatory position and discover FDA Guidance Documents and harmonized standard that apply to your product.
4. C² will review your documents and create those necessary to qualify for regulatory "approval".
5. C² will review / prepare engineering documents as we would separately agree.
6. C² will advise you of additional documents essential to achieving a favorable decision.
7. C² will screen the documentation and testing to minimize the possibilities of questions.
8. C² will create, write and file the actual 510(k) application.
9. C² will monitor the application and assist you in answering regulatory questions.

Compliance Consultants has so many 510k applications ...to us- its like digging a hole. Its just hard work. You tell us where to dig and how deep. We do the rest.





We do the hard work. If we hit rock, we keep digging. Our back might get sore, it might be hot outside... we have seen it all!