Welcome to Compliance Consultants...

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

A typical Device... Most of the devices we work with are complex or "high risk" class II devices. High risk is defined from the viewpoint of the inventor not the FDA. High risk means that if the inventor is not able to reach a financial "breakeven" point within a planned period, their budget would be exhausted. The inventor may fail regardless of the potential success of the medical remedy/ diagnosis that the technology has to offer the patient.

Often clients seek us out also when their device is so revolutionary that it may NOT receive a Class II substantially equivalent. Sometimes our clients cannot afford to conduct a clinical trial or the clinical trial has so little accepted definition that even after a trial the FDA would question the structure of data. Our clients depend on us to characterize the device as to not incite the FDA to require a clinical trial.

In addition to that risk, the invention itself often has technological difficulties due to the embodiment of new technologies that have never been integrated to work together before. Refer to our technologies for a tabulation of the various technologies that we have worked on.

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