Although most of our early experience is in engineering management at Fortune 500 companies, in the last 24 years, we created 510(k)s for over 100 small, venture backed, start-up medical device manufacturers. Compliance Consultants has the ideal skill set that every regulatory consultant wishes they had! We understand your challenges and limitations. We can add value to your product - not only by obtaining regulatory approval but by identifying improvements in your development.


Attorneys are great for wills, divorces and appearing before a judge. Attorneys are schooled in legislative matters interpreted by case law. Regulations are promulgated by specialists in subjective prospectives. Attorneys are not trained in regulatory specialties but we are. We are skilled in science, product development, testing and repeatability.

Choosing a regulatory consultant for a 510(k) submission is more than a coin toss!

We are skilled at appearing before scientific specialists at the FDA / CDRH.