About Us

FDA 510(k) Consulting specializes in regulatory and compliance related submission services to manufacturers, importers, and suppliers of medical devices. Our FDA 510k Consultants are experts in medical device 510(k) Submission Consulting for FDA Approval . Our consultants got over 30 years of medical product experience, and familiar with FDA’s medical device product classifications. We are transparent and will make timely and effective regulatory submissions to the FDA for a fixed fee. We ensure to file appropriate notifications and filings for timely approval.

Since FDA 510(k) Consulting got a long-standing relationship working with the FDA and a track record of success in medical device 510(k) Submission consulting for FDA Approval and clearance, we are proud to assist our clients to successfully navigate the 510(k) submission process. As your FDA 510k consultant, some of the services that we provide include evaluating your medical device’s classification, perform GAP analysis, prepare the regulatory strategy, collect the necessary data, safety and performance test report and documentation to complete the 510(k) Submission. As your FDA 510(k) consultant, our goal is to remove the stress and burden of the 510(k) submission work from your shoulders by bringing regulatory and compliance skills, so that you get the desirable outcome from the U.S Food and Drug Administration (FDA) at the end of the submission process.

Read More

Our Services

Why Should I choose
FDA Consulting for my 510(k)?

There may be several factors in your 510k consultant selection process, but you should consider some of the most important factors listed below in your FDA 510k Consultant selection process:

We serve companies of all sizes and product classifications within your budget. Please contact us for a quote for your submission
Time is money!

We specialize in Medical Device 510(k) Submission Consulting for FDA Approval /Premarket Notification. Our FDA 510(k) Consulting firm’s goal is clear your medical device for the U.S. market in just four months. We do it with a FIXED FEE that saves you a lot of money. Our focus would be to get your product cleared quickly, efficiently and cost effectively. Contact us today for a free 30 minute consultation.

Contact Us Today