"Big companies" developing new medical devices may be able to pay for former FDA/CDRH Section Heads /Reviewers at a fancy regulatory consulting firm . This appears to be a "safe" bet and worth the cost if you must explain a decision to your boss. But, ask that same "former FDA/CDRH Section Heads /Reviewer" for a technical regulatory plan, ask for his assurance that he will be there to do the work and agree on fixed-fee cost. You will get a different presentation.

A distinction worthy of consideration

Some regulatory consulting firms employ former FDA CDRH Section Heads /Reviewers, then reference this experience as the pinnacle of excellence to win your business. While that experience may serve some applications, its different than what you may need. It is like hiring the world's best editor... thinking an editor could write the most interesting novel. Editors and writers are different. Editors only function after the creative effort is finished. Writers must create from blank paper. We create 510(k) submissions from blank paper - early in your product schedule.


At Compliance Consultants- we are creative. We understand product development, engineering and FDA regulations. We have felt the schedule and budget pressures at struggling young companies. We create an application based on your issues, threats and assets. We tune it and shape it to fit through the FDA review process.


Statements about experience can be misleading. Its like a boater boasting of 30 years experience when he has really only fished in a local harbor. He might have 3 years experience 10 times. Compare this to a sailor who sailed many oceans on different boats in bad weather in different seas. Who has the real experience? Who would you want at your helm in a storm?