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The 510(k) process
Companies must file a 510(k) Premarket Notification to receive FDA "approval" to market medium-risk medical devices. A 510(k) petition is a technical document. It is designed to demonstrate the product's safety and effectiveness.
With over 25 years of experience, we help companies maneuver through FDA's complex medical device pathway.
We also help clients with other issues related to bringing those products to market.
While clients demand prompt service, something few consultants deliver, they also appreciate our affordable fixed fees. This combination of high quality and fair price delivers great value for companies like yours.
"I was impressed with their determination to get our medical device cleared. Very good service. Couldn't have done it ourselves, not in this regulatory environment."
Time is money!
Our goal is to clear your medical device for the U.S. market in just four months, while also helping you save money.
We do that by focusing on FDA's Premarket Notification pathway. Instead of promising everything to everybody, we specialize in getting your product cleared quickly, efficiently.
Contact us today for a free 30-minute consult.