Darci Diage – Manager, Special Regulatory and Compliance
Darci Diage specializes in start-up medical device Quality and Regulatory implementation and support. Her expertise is in concept to commercial medical device compliance for FDA and EU regulators. Darci has over 18 years of experience in the medical device industry focusing on manufacturing, design control, risk management and product development activities to support market approval in the US and Europe. Her primary role and responsibility is to interface between Cognos Therapeutics, the FDA, pharmaceutical partners, and other regulatory bodies to help advance Cognos Thx drug delivery technology. Additionally, Darci is responsible for quality system implementation and regulatory strategy to ensure timely and effective premarket review of Cognos Thx technology platforms by regulatory agents. Darci is a certified Biomedical Auditor. She holds a Masters of Biomedical Laboratory Science from San Francisco State University and a Bachelor’s of Science in Molecular Biology from Sonoma State University. She is a consultant to Sensor-Kinesis Corporation and is employed as a Principal Medical Research Manager at NAMSA.