In 2005, Ken Block Consulting (KBC) began as the one-person venture of Kenneth L. Block, whose background includes an undergraduate science degree in physics and more than 35 years of experience in FDA-regulated medical device and laser product technologies. Mr. Block worked within manufacturing, validation, quality and regulatory areas for several Class II medical device companies (including senior management positions) before starting his consulting company. He has also earned the Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society (RAPS).
KBC was originally formed as a sole proprietorship in Dallas County, Texas, and began in a small 600 ft² office in Richardson, Texas (subsequently incorporated as Ken Block Consulting LLC). Two employees were soon hired, with more office space and employees subsequently added as client work steadily increased. In 2009, an office in Tokyo was added as a hub for clients throughout Asia, along with the formation of Ken Block Consulting LLP in Japan (subsequently incorporated as Ken Block Consulting Co., Ltd. in 2017). In 2018, Ken Block Consulting France SAS was formed as a regional hub for clients throughout Europe, with an office established in Paris. The US location of KBC is now headquartered in a 3200 ft² office in Richardson that serves as the central hub for consulting projects performed worldwide, coordinated among our three global locations.
Over the years, Mr. Block and other KBC employees have authored original informative content that has been presented in published articles throughout the global medical device industry, given dozens of invited speeches at medtech events worldwide, and participated in conference panel sessions covering a wide variety of regulatory topics. KBC work has even been referenced by others as both law school citations and industry article references. These many accomplishments have contributed to our international reputation as industry experts.
Ken Block Consulting is dedicated to providing the highest quality regulatory, validation, quality system and related consulting services to medical device companies worldwide. The experienced KBC team is committed to contributing value, establishing trust, showing respect, and delivering success to our clients. With this approach, our higher goal is to empower clients with the knowledge and ability to perform more effectively in the future.
KBC will always protect client confidentiality and provide honest and accurate answers. We follow a policy of ethics and transparency with our clients so that they, in turn, can approach regulatory authorities with the information and confidence necessary to succeed. Many clients have provided testimonials to the excellent work and successes achieved by KBC, both for regulatory projects (including FDA submissions) and quality system projects (including FDA inspections).
KBC is known for tackling unique challenges and complex projects with intelligence, creativity and flexibility for clients ranging from small startups to large multinationals. These core principles, along with our experience and approach, are the basis for the KBC vision, mission, and values.