About

Company History

In 2005, Ken Block Consulting began as the one-person venture of Kenneth L. Block, whose background includes a bachelor degree in physics and more than 25 years of experience in FDA-regulated medical and laser device technologies. Mr. Block has also earned the Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society (RAPS) and is a Senior Member of the American Society for Quality (ASQ). Mr. Block held manager- and director-level quality and regulatory positions in several Class II medical device companies before starting his consulting company. Ken Block Consulting was formed as a sole proprietorship in Dallas County, Texas, and began in a small 600 ft² office in Richardson, Texas. Two employees were hired not long after establishment, with more office space and employees subsequently added as client work steadily increased. In 2009, an office in Tokyo was added, along with the formation of Ken Block Consulting LLP in Japan. As of 2015, the company is headquartered in a 3000 ft² office in Richardson that serves as a hub for consulting projects performed worldwide.

Our Approach

It is the goal of Ken Block Consulting to provide the highest quality regulatory services to medical device companies worldwide. KBC is committed to providing value, trust, and respect to those we interact with, and our goal is not simply to solve problems but to empower our clients in the process so that they can deal with issues more effectively in the future. 

Values

Ken Block Consulting will always protect client confidentiality and will always 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 knowledge and confidence necessary to succeed.