Denise Forkey

Denise Forkey is the Director of Human Factors Strategy - Advisory at ClariMed. With over 25 years of experience in the medical products industry, she is an expert in implementing usability engineering processes, conducting use-related risk analyses, formative evaluations, and validation testing for a wide range of medical technologies – from home-use devices to complex robotic surgery systems. Denise develops human factors submission strategies and documentation for FDA and international regulatory compliance, successfully guiding clients through submissions and audits. She leverages her deep expertise to help clients bring innovative, safe, effective, and easy-to-use medical technologies to market.