Qualifying

Our experience is: you will not receive funds from “mainstream venture capitalist” -for a medical invention - without FDA “approval”. Any due diligence investigations from potential investors would surely discover any weakness in your FDA plan if the plan failed to achieve the recent initiatives, which require: design controls, compliance to performance specifications and a product testing program.

To present a plan that will withstand the scrutiny of potential investors during the due diligence investigation requires an irrefutable engineering development plan. This plan must be concurrent and coincidental to the FDA regulatory plan. This plan must establish FDA approval to a reasonable certainty.