Mrs. Lopez joined AutoGenomics in 2006 and has over 30 years of regulatory/clinical affairs/quality assurance experience in medical devices and pharmaceuticals companies. Her experience includes US and international regulations related to clinical trials/premarket submissions (PMA, IDE, 510k, MDD/IVDD) and quality systems (FDA QSR, ISO), as well as activites related to strategic planning, contract manufacturing, and mergers/acquisitions. Mrs. Lopez served as Vice President, Regulatory & Quality Assurance for Novatrix Biomedical, Director of Clinical Affairs at Micro Therapeutics, and Director of Regulatory Affairs at Cryogen. Mrs. Lopez holds a B.S. in Chemical Engineering from the Philipines, and a M.S. in Operations Research from Stanford University.