Superior service + Competitive price

We all know that Good Service + Affordable Price = Great Value. We resolve this equation in your favor and reduce any uncertainty in dealing with the U.S. Food and Drug Administration’s (FDA) regulators. We offer you our well-experienced team of regulatory consultants to provide you the best mix of superior service and competitive price.

Our winning combination

  • Blue checkmark in a blue circle

    Good service

    You want a consultant with experience in your medical device. Unfortunately, that is almost impossible to find, short of creating your own regulatory department (which is what large firms do). There are thousands of medical devices. Each has its own unique safety and effectiveness challenges. But there are relatively few professional 510(k) consultants.

    We’ve found that your best bet is to hire someone with broad general experience in testing for electrical safety, bio-compatibility, sterilization and performance, but dedicated to understanding your technology, regardless of how long that takes.

  • Thumbs-up with a dollar sign

    Affordable price

    Our pricing is customer friendly because it is both reasonable and transparent.

    Most consultants charge a fee with a catch–if they spend more than a certain number of hours, they charge you more. But 510(k) engagements always take longer than anticipated.

    Unlike other consultants, we work for an agreed fixed fee. And it won’t go up, regardless of how much time we spend to get the job done. We’re there for you all the way. We put that in our contract.

    So hire our team of well-experienced regulatory consultants and receive the true “best value” for your regulatory needs.

Our recent technologies

Below are some interesting devices we cleared recently through the 510(k) program.

Recent testimonials

We frequently hear positive words from our clients, and we are proud to highlight some of them in this section.

  • “We contacted FDA 510k Consultants to save a 510(k) we prepared and submitted. But we couldn’t finish software development, so the petition died. They proposed an outside-the-box solution and refiled a new 510(k) which sailed through. Now sales are over a million dollars a year for that product. We should have hired FDA 510k Consultants from the beginning. Our experience with European regulatory misled us into thinking we could tackle the U.S. without an expert’s guidance.”

    Patrick C., International Product Manager, France
  • “I hired FDA 510k Consultants to prepare three 510(k)s for different products. If I had followed John’s advice, all would have cleared promptly. Highly recommend their service. FDA is the hardest regulatory agency to deal with. Let an expert save you time and money.”

    Raymond R., Founder & President, South Korea
  • “My company recently entered U.S. market with a high-end radiological device. We couldn’t have done it without much hand holding by FDA 510k Consultants. My firm will hire them for a second product when design and testing are complete. The team provided prompt, professional service. They are great.”

    Yoshi K., Export Sales Director, Japan
  • “We were working with a private equity firm that discovered our supplier did not have a 510(k) for our main product. John guided us through this delicate situation. During this period, one of our competitors got caught in a similar situation–and FDA shut down sales of an entire product line for six months.”

    (name withheld), President, USA
  • “Very reasonable price. Prompt service. Excellent guidance. As a small business bringing its first medical device to market in the U.S., we relied heavily on the team at FDA 510k Consultants to walk us through the process, and to understand what FDA expected.”

    Mariana F., Marketing Director, Brazil
  • “I invented a medical instrument and was told I needed 510(k) approval from FDA. When my first import shipment was stopped at customs, I contacted FDA 510k Consultants and received great news–the device was actually 510(k)-exempt. They saved me thousands of dollars.”

    Dr. Kermit M., Inventor, USA