FDA 510 K Consultant Testimonials

Our FDA 510K Consultant and 510K Services Testimonials

"We contacted Denterprise International to save a 510(k) we had prepared and submitted without a consultant’s assistance. Denterprise International spent days working with FDA, but in the end our engineers couldn’t finish development of the device firmware. So the petition died. Denterprise International came up with a brilliant plan for the resubmission, which sailed through clearance. Now sales are over a million dollars a year for this new product. We should have hired Denterprise International from the beginning. Our direct experience with regulatory agencies in Europe and other countries misled us into thinking we could handle an FDA petition by ourselves."

– Patrick C., International Product Manager, France


"I hired Denterprise International to prepare three premarket notifications for related but separate medical devices. If I had followed their advice from the beginning, all three 510(k)s would have cleared promptly. Highly recommend their services. In my experience, FDA is the hardest regulatory agency to deal with in the world. You need an expert to guide you."

– Raymond R., Founder/President, South Korea


"My company recently entered the U.S. market with a high-end radiological device. We couldn’t have done it without a lot of hand holding by Denterprise International. We were so grateful that my firm will hire them to prepare a 510(k) for a second product as soon as design and testing are complete. They provided prompt, professional service. I highly recommend them."

– Yoshi K., Export Sales Director, Japan


"Very reasonable prices, prompt service, excellent guidance. As a small business bringing its first medical device to market in the U.S., we relied heavily on the whole team at Denterprise International to walk us through the process, and also to understand what FDA expected. Many thanks!"

– Marcelo T. and Mariana F., Founder and Marketing Director, Brazil


"I invented a medical instrument and was told I needed 510(k) approval from FDA. I was fortunate to have contacted Denterprise International, because they researched the product and gave me great news – the device was Class 1, 510(k)-exempt. Their action saved me many thousands of dollars."

– Dr. Kermit M., Inventor, USA


"Our large medical supplies firm developed a high technology device but wasted almost a year – at a cost of nearly $20,000 – struggling with one of the “big” FDA consulting firms to get regulatory approval. Then we switched to Denterprise International. Now we are on track to bring this important product to market with FDA clearance. This step will significantly improve sales throughout Latin America. Thank you for helping us through this difficult period."

– Marcelo M., Export Manager, Mexico


"We recently developed a medical device fabricated by 3D lithographic printer. Denterprise International was so interested in helping us clear it that he flew to FDA’s Headquarters in Silver Spring, MD, for a two-day public symposium on this technology. Right after that trip he completed the 510(k) petition and submitted it to FDA. That level of dedication was impressive."

– Jason L., Principal Scientist, USA


"Our company was working with a private equity firm when the issue of regulatory compliance arose. We contacted Denterprise International and discovered our supplier, a large U.S. chemical company, was selling us a finished medical device without FDA clearance. Denterprise International worked with us to correct this delicate situation; one of our competitors got caught in a similar situation recently, as FDA shot down their ability to market an entire product line for six months."

– Name Withheld, President, USA