MDCI is a full-service consulting firm and contract research organization (CRO) that helps emerging and established firms commercialize novel and innovative medical devices, in vitro diagnostics, and combination products. Clients trust MDCI to deliver customized strategic guidance and creative "hands-on" solutions to address their unique regulatory, clinical trial, and quality assurance challenges at every stage of the medical device product lifecycle.
MDCI has helped hundreds of clients conduct successful clinical trials, achieve regulatory clearance and approval, and maintain compliance for products in the U.S. and internationally, including meeting FDA submission requirements, CE Mark requirements, and Health Canada requirements. By leveraging our comprehensive knowledge of FDA and international regulations, clients capture and grow market share, increase productivity, and stay competitive in an increasingly complex global marketplace.