FDA, 510K, PMA, CDRH, ISO, IEC, AAMI, medical devices, invention,

 

  Welcome to Compliance Consultants...

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

 

Our site is designed to inform you about subjects critical to your success. Usually our clients are trusting us with their future. We do not take that obligation lightly. This site will continue to grow to cover pertinent issues. Visit us at http://www.complianceconsultants.com.

essentials

Venture capital firms take only identifiable risks. The FDA “approval” is usually the greatest risk. Investing in a medical device where the FDA plan fails to achieve an FDA “approval” before the break-even point is NOT an investment any advisor could endorse. That is almost like presenting a plan to potential inventors showing a plan where only by a miracle - could the goal be reached. Investors would fee from such a plan. Showing them a plan without an irrefutable plan is virtually asking for a miracle.

 

Any medical device plan must show a clear method to either:

·        submit the application to the FDA, or

·        achieve FDA approval.

 

When C2 conducts an FDA project on your invention, that is a significant step in the commercialization of the invention.

 


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

 

 

 


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  Compliance Consultants
1151 Hope Street
Stamford CT 06907 USA
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