Instructor

Clarisa A Tate LinkedIn

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CLARISA TATE, B.S.M.E., M.S.R.A, is director of Regulatory Affairs, USA for Ypsomed AG. She has almost 20 years of medical device industry experience and has specialized knowledge in manufacturing, facilities, quality, engineering, clinical quality and auditing, as well as pre-market and commercial regulatory compliance. Areas of expertise include U.S. and international regulatory submissions and compliance, working with startup and small companies, taking new products to clinical trials, approvals, post-market surveillance, and building a quality system from the ground up. She has worked at Flowmedica (now Angiodynamics), Stryker Endoscopy, Abbott Vascular Devices (formerly Perclose), Halt Medical (now Hologic), Phoenix Clinical, Dr. Ashton Essentials, and AIRx Medical. She received her bachelor of science degree in mechanical engineering from Santa Clara University and her master of science in regulatory affairs from Northeastern University.

Associated Program(s)

Clinical Trials Design and Management Medical Device Quality and Design Regulatory Affairs

Post-Market Regulatory Obligations for Medical Devices