Beware...of the many "big"
regulatory affairs firms using
"special effects" to demonstrate
competence in selling you - then
use subcontractors to do the real
work. We do all our Work!





...device approvals since 1987...

Nobody is more qualified in 510(k)s than



Compliance Consultants is a recognized leader in developing new medical devices and obtaining U.S. Food & Drug Administration "approval/clearance" for medical devices. We have assisted medical device inventors and manufactures through 22 time zones in developing and shaping devices to fit through the FDA approval process. We talk "good science" and that best serves you.


No matter how many floors our competition may have in a D.C. beltway skyscraper, no matter how many secretaries they have, no matter how many attorneys they have (waiting to charge you by the hour).... no matter how many "former FDA reviewers" they claim.... ask them for a regulatory plan and ask to shake the hand of the person who will execute that plan.... You will choose us every time.... and we charge on a fixed-fee basis. We charge less for more!

How we charge less for more!

As development engineers, we submit your 510(k) faster because we know product development. We limit risk and charge a realistic fixed-fee. No middle man!

Why we are different...

Most regulatory compliance professionals have "quality assurance" backgrounds - as auditors. They only act as critics. They contribute after your product is formed and tell you what is wrong. They are editors not writers and deal in "after the fact". Not us. We are development engineers. We participate in a wider spectrum of development activities on an array of devices. Compliance Consultants works from the start and assists you in shaping and creating the device so the device meets regulatory requirements. We start sooner and reach the end point -sooner. We do not audit- we create. We move your project into a different domain. Many of our clients achieve ISO-13485 certification as part of our project. Once we "come on board" your FDA dilemmas vanish!