FDA Submission Projects  

"Our team spent the prior year with another FDA consulting firm submitting 3 pre-subs and endless supporting material to the FDA with very limited success.  We paused that work and engaged KBC for a second opinion.  Within one review he identified areas we could revise in our approach to the FDA that led to a Breakthrough Device Designation in a matter of months.  Our team witnessed Ken’s perfect execution of a Hail Mary.  Needless to say, we would highly recommend his firm." – M.D. & Chief Scientific Officer

“This is an incredible achievement [510(k) submission] that only came about due to hard work and a commitment to make this a reality. It is a significant milestone that will provide a lasting impact on our ongoing capabilities. Thank you so much for your collaborative efforts on our behalf.” – CEO

“I'm really happy with the long-awaited 510(k) clearance. We couldn't have made it this far without your help. Thank you very much for your cooperation over the long term.” – Project Manager

“I would like to give the highest recommendation for the outstanding job Ken Block Consulting has performed and continues to perform for my company. Mr. Block and his consultants outlined a unique and successful strategy for us to obtain 510(k) clearance for our first-generation device. He then created a strategy of serial iterations of the device to get it to the point of market readiness. This strategy has been reviewed and approved by our primary funding agency, as well as the FDA.” – Founder & CEO

“Thank you, Ken, for all you have done. I know you were key to our success in this [510(k) submission] and we appreciate all your support and hard work to get us here!” – President

"The team at KBC organized a superstar application for Breakthrough Device Designation. The application was organized, persuasive and comprehensive. We approached the FDA with confidence that our device met the requirements of the Breakthrough program." – President

“As a Swiss Medtech SME [small / midsize enterprise], we are working with KBC to support our RA team for the US FDA related topics. So far, we succeeded with three 510(k)s and one FDA inspection. If we have to describe them with three words, we would use: professional, reactive and listening.” – CEO

“Little shots can become big shots when they use Ken Block Consulting!” – President

“Our company is very happy to have obtained the clearance this early for Traditional 510(k), and we really appreciate your big effort.”  – Global RA/QS Manager

“We recently finished an FDA pre-submission meeting. Ken Block did a fabulous job of presenting our case. Everyone in the room was extremely impressed. All of the comments that returned from that meeting were positive. Some members stated they had never seen a better presentation. It made me proud to have engaged Ken Block and his team to get us the proper strategy and to be able to present our case.” – Founder & CEO

“Thank you for your effort for the Substantial Equivalence. I see that an additional SE Letter is being issued, too. We are truly thankful for the KBC work.” – Project Manager

“Ken successfully strategized, orchestrated and executed not just one but two medical device FDA clearances for our company. Throughout the entire process he coordinated every resource necessary from his team and mine by facilitating everyone’s talent into one collective voice.” – President

"We are happy with the guidance that the KBC team has provided for our engagement with FDA. We feel much more confident in our strategy and options now.” – Quality, Regulatory, and Clinical Trials Manager

"You and your team were pivotal in our company's success as we transitioned from a Class I (MDDS) to a Class II (510(k)) medical device. With your guidance in place, we were able to remain in compliance while rapidly growing our business, all the way through to the acquisition of our company." – CEO/Founder

“Of note, one never completes a journey without staying the course. Thanks for supporting us to the finish line [510(k) submission].” – CEO