Darci Diage specializes in start-up medical device Quality and Regulatory implementation and support. Her primary expertise is in the areas of implantable cardiovascular, combination product and active 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 concept to commercial product development activities including preclinical and clinical submissions. Her primary roles and responsibility is to interface between Cognos Therapeutics Corporation (Cognos), the FDA, pharmaceutical partners, and other regulatory bodies, where Cognos utilizes their drug portfolio in conjunction with its Sinnais smart implantable pump as well as other compatible companion drugs. Additionally, Darci is responsible for developing guidance and regulations to clarify the use of combination products, and to ensure timely and effective premarket review of combination products by regulatory agents.
Darci holds an ASQ Biomedical Auditor and Lead Auditor Certification and is currently a member of the American Society for Quality (ASQ). 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.
TO THE POINT
- 18 years of experience
- Expertise in Combination Product Regulatory and Compliance for the FDA and EU
- Holds an ASQ Biomedical Auditor and Lead Auditor Certification
- Member of the American Society for Quality
- Has managed risk management and concept to commercial product development activities for medical device technology interests
- Bachelor’s of Science in Molecular Biology from Sonoma State University, Sonoma, California
- Masters in Biomedical Laboratory Science from San Francisco State University, San Francsco, California