Kelly has more than 20 years of experience in the medical device industry and more than 12 years of experience in global medical device clinical research. She has a strong clinical background from her positions as a Medical-Surgical ICU RN, Open Heart Surgery ICU RN, and Cardiac Cath Lab RN early in her career. Previously, Kelly has held multiple Vice President of Clinical Affairs positions for medical device companies where she strategized, designed, and executed global clinical trials including international multi-center FDA-regulated IDE / NSR studies for new device approvals, double-blind randomized controlled device trials, and post-market studies.
Kelly holds a B.S.N. degree from San Jose State University, and M.S. from UC San Francisco. Kelly is now President and CEO of a premier consulting organization providing expertise in clinical, regulatory, and quality consulting. The clinical and data management operations focus on expert design and conduct of research with a personal approach to meet medical device companies’ corporate goals and promote successful execution of all medical device trials from FIH to feasibility to pivotal trials to post market studies.
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