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Is your project funded?

we can walk you through the venture funding process...

Most new medical devices either succeed or fail due to their budgets. We have seen many deserving projects fail and undeserving projects succeed due solely to their funding position. A realistic FDA plan is essential before any investor would fund a medical device. Our experience is: "mainstream venture capitalist" require a impeccable FDA plan prior to funding. Any due diligence investigations from potential investors will discover any weakness in your FDA plan.

We direct the regulatory development that drives the engineering development of new medical inventions to ensure money, at risk is not spent in efforts which will not benefit your ultimate goals. We participate in the engineering development as part of a feed back system to ensure progress. In the commercialization of innovative medical devices, we offer the ability to:

  • Guide early development to ensure your invention is on track.
  • Define issues to ensure your invention meets FDA requirements.
  • Identify potential partners to share in the expertise and risks in distribution.
In every case, our advice is to start your FDA plan as early as possible, then:
  • Create all design controls, such as: the requirements, performance, product, test specifications, as well as a safety plan and failure analysis/effects.
  • Recruit multiple sources for all suppliers and fabricators.
  • Then, while building the authentic pre-production device {supported by all qualification and recurring tests} file the FDA submission {which had guided earlier efforts}.

 

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

 

 

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Compliance Consultants
1151 Hope Street
Stamford, CT 06907 USA
v-203 329 2700
f-203 329 2345

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