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Ms. Spencer brings over 20 years of direct medical device experience specializing in the development of strategic regulatory submissions as well as the hands-on design and implementation of quality systems in compliance with FDA and international standards. A veteran of multiple medical device start-up ventures, GluMetrics is Ms. Spencer’s sixth start-up with four of the previous companies being acquired and one becoming a public entity. Helene is active in numerous professional organizations and currently serves on the Board of Directors for the Orange County Regulatory Affairs Discussion Group (OCRA). | 