We give you engineering direction for your medical device. You no longer go in design circles to meet FDA requirements.

We commercialize medical devices. We start when your design is on a napkin. We shape your design to fit through the FDA and we "get it through" the FDA's approval cycle. We accelerate the "right " project in the "right" direction. We advise what should be done, must be done, what does not have to be done. We identify features that are risky and features that may create issues. We analyze device enhancement and identify any jeopardy. We create alternative implementations to minimize risks. We advise "what assortment" of documents is required by the FDA to control a particular risk. We can do a risk analysis, design for hire, and detail test planning. The conclusion of our efforts position you for ISO approval.

You are relieved from evaluating regulatory issues. You will no longer do more than necessary to ensure an FDA approval. You are free to do what you do best.

On any "first of a kind" project, we will save you more money than we charge. We are not just cost effective; we integrate the regulatory process as a contribution to the product development. We produce a better faster, cheaper overall project. We write and submit the most impressive applications (that is what reviewers at the FDA say!). Our services cover: from project launch until the FDA approves the device whether it is three months to three years. Not only do your receive FDA approval, you travel a clearer, more certain path. This reduces your risk and makes the project run smoother.

On difficult, risky, uncertain, new, innovative projects, we shine. We add certainty and direction to "first of a kind" medical devices. We reduce risk. The project will not languish waiting for a regulatory direction. Bring us on board for one medical device project …. you will never feel confident working without us.

  Copyright by Compliance Consultants, Stamford, CT 06907, September 2001