Regulatory Advisor
Dr. Radcliffe (Radcliffe Consulting, Inc.) has more than 20 years of experience assisting medical device and diagnostics companies with technical assessment, marketing, and clinical/regulatory issues. Gail was awarded her PhD in Molecular Biology from Brown University and completed a post-doctoral fellowship in molecular immunology at the University of Massachusetts Medical School. Afterward, she worked at GENE-TRAK and then Cytyc, until 1998, when she founded Radcliffe Consulting, Inc. Dr. Radcliffe consults with medical device companies, for market research, regulatory strategy (IVD vs. CLIA lab) and submissions, quality systems development, and clinical trial support. Her experience includes a wide range of products in digital pathology, laser dissection devices, companion diagnostics, and multiplex molecular, POC and CLIA Waived in vitro diagnostic devices.