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