Karen Richards is the Senior Vice President of In Vitro Diagnostics and Quality within Precision for Medicine’s Tranlational and Regulatory Sciences Practice, which was established to provide value-added scientific and regulatory solutions for development, marketing authorization, regulatory complicance and stewardship of innovative healthcare products. Ms. Richards has worked in the in vitro diagnostics (IVD) regulatory, quality, clinical trial and compliance areas for over 30 years. In that time, she has been responsible for multiple regulatory submissions and approvals in the U.S., EU, and rest of the world for IVD products and biological diagnostic assays for use in blood screening. She has also been responsible for approval of laboratory tests in all US states requiring a license, including New York State, as well as certifiation to CAP. She has implemented quality systems, from the ground up, for diagnostic products to meet the requirements of US FDA, ISO 9001, ISO 13485, CLIA, and CAP. She also has developed and implemented clinical trials for multiple products that were used to generate data for regulatory submissions. Ms. Richards served as the Compliance Officer for three companies, covering both traditional diagnostic products as well as clinical laboratory tests. Ms. Richards has served as a board member to the Association of Medical Diagnostics Manufactureres (AMDM) during various terms since 2003. This organization is dedicated to the IVD industry and provides educational programs with FDA’s Center for Devices and Radiological Health’s (CDRH) Office of IVD and Radiological Health (OIR).
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