How we execute a 510(k)

Compliance Consultants protects your proprietary and intellectual property regardless of the patent position. After our first conversation, we offer you a confidential agreement. We develop a regulatory plan to meet your schedule, cost and performance.


We are "people-people". We talk on the phone. We come visit you. We talk medical device sales, marketing claims, target market, product launch date, selling price, distribution, advertising and sales to patient, physician or distribution network.


Compliance Consultants reviews your medical device in all aspects as part of developing a FDA, CDRH, 510(k) regulatory plan. We look, touch and feel your product. We go to the shipping department and see what the shipping cartons look like, we review you engineering drawings, we study your marketing / distribution and pricing. We always consider any device from the patient's perspective as does the FDA / CDRH and work with your people in creating a process to achieve success.

Wherever you are in the world-we come see you