Ken Block Consulting

Ken Block Consulting is a private medical device regulatory and quality consulting firm focused on helping device manufacturers meet FDA and other market-entry requirements. The company provides regulatory strategy, establishment registration and listing support, FDA submission assistance, inspection readiness, quality systems consulting, validation, risk management, and related compliance services. Founded by Kenneth L. Block, the business began in 2005 in Texas and has expanded internationally with operations serving clients in the U.S., Japan, and Europe. Ken Block Consulting does not appear to be a therapeutics developer; rather, it operates as a specialized medtech advisory firm supporting commercialization and compliance for medical device companies worldwide.