Kenneth L. Block

Kenneth L. Block, RAC, is an experienced professional in FDA regulatory services and quality assurance, currently serving as President of Ken Block Consulting since April 2005, providing services such as QSR compliance audits and 510(k) applications, with a focus on the Asian market. Previous roles include Director of Quality and Regulatory at Galt Medical, overseeing regulatory activities for vascular access products, and Quality Engineer at Neuro Resource Group, where implementation of a QSR compliant quality system was key. Kenneth also held positions as Director of Quality Systems and Regulatory Affairs at D4D Technologies, Director of Quality Assurance and Regulatory Affairs at Estill Medical Technologies, and worked as an independent consultant before that. A strong engineering background includes a role as Senior Manufacturing Engineer at Quest Medical, where significant process improvements and product innovations were achieved. Kenneth holds a B.S. in Physics from Rose-Hulman Institute of Technology.