FDA Submission Projects  

“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

Quality System Projects

“In our firm’s 25+ year history, KBC is one of the most experienced, down-to-earth, and no-nonsense groups around.  Most recently, KBC has helped our client further refine and implement a compliant and manageable quality system that they are comfortable with.  We highly recommend KBC.” – Partner

“We appreciate all of you and the KBC team's support for our FDA inspection. Without your help, we could not have coped with this matter.” – Vice President

"Ken came into a developing situation and was able to quickly and accurately assess our quality, regulatory and compliance landscape. He then dove in and handled FDA communications, a recall, supplier audits and CAPAs. This allowed us to move forward in important areas while filling full-time positions" – Member, Board of Directors

“I would like to thank you and your employees for the excellent support before and during the FDA inspections last week. As you have probably been informed, both inspections passed without any 483 observation.” – Global QA/RA Director

“I give the highest recommendation to Ken Block and his team. I find them to be of the highest quality in ethical standards. They are a ready and complete resource for the regulatory needs of our startup company for becoming a real medical device company. We have built our quality system based upon the recommendations and continuing education that has ensued.” – Surgeon & Founder

“I am glad to know very, very good news from you [issuance of FDA inspection close-out letter]. Again, thank you for your strong support always.” – General Manager

“Many, many thanks to you and everyone on your team for the FDA inspection this time. Thanks to all the KBC efforts, we could go through this inspection without any major problem. I really appreciate you and your team from the bottom of my heart.” – President & CEO

“We really appreciate your and your team's kind support for MDSAP audit. The audit by TUV-Rheinland was finished with no nonconformance. Once again, thank you very much for your kind support and I kindly ask you for your ongoing support.” – Corporate Vice President

“I have seen Ken busy as the dedicated business owner of Ken Block Consulting (KBC) while developing quality control measures for testing our prototypes, implementing standard operating procedures for our quality manual, and working long hours with a “whatever it takes attitude.” He is at the forefront of understanding FDA and ISO guidance/regulations, and I would highly recommend Ken to assist with any consulting in this arena.” – President

“Thank you very much for your help with the gap audits, procedures, record reviews, and pre-inspection/during-inspection assistance, guidance and interpreting, and supplementing the FDA inspector in accurate English. The very good results of this inspection are largely due to your company's efforts.” – Quality Manager

“The seminar was more active than expected, and the audience eagerly listened to your lecture. This was a beneficial experience to learn the 510(k) process based on the actual situation.” – R&D Manager

“We had engaged KBC to assist us in the preparation for the FDA inspection. The support given by the KBC team has been very useful. They have helped us to refine our procedure and process, conduct competent training, which effectively puts us in a better situation during the FDA inspection. We are very grateful for the support from the KBC team.”  – QA Manager