Welcome to Compliance Consultants...

...the more you learn...the more you will want us for FDA!

We develop a plan.

After our research, we develop a working plan that addresses the regulatory, engineering, testing, documentation, clinical and fabrication aspects up to the moment the device can be sold in the U.S. We investigate your regulatory issues and device a plan so your development testing is able to support creation of the FDA application. We look at the fundamental scientific percepts upon which your device works. We derive tests necessary to substantiate that performance. We derive the various development stages necessary to test these scientific percepts. We establish the authentication of a calibrated dose or calibrated treatment level that is delivered to the patient. This is fundamental to the design controls specified by the FDA. Seldom do we complete a plan that does not uncover surprises. We propose a project to achieve your objectives. Our program normally is to research, create, prepare, submit, and follow through to regulatory acceptance, the products or programs for which we quote. We work with you or windexver you direct us to, on an accelerated schedule with specific milestones.

copyright by Compliance Consultants, Stamford, CT USA, September 2001