Kay Fuller

President, Medical Device Regulatory Solutions

Kay Fuller

President, Medical Device Regulatory Solutions

Biography

Ms. Fuller has more than 39 years experience developing and commercializing complex cardiovascular and neurosurgical medical devices. She has led successful global clinical studies and regulatory marketing authorization submissions for more than 38 Class II & Class III medical devices and combination products, via the U.S. FDA IDE, IND, 510(k), PMA and E.U. CE mark processes, which have enabled over $5B in global medical product sales. She founded MDRS, LLC, a national regulatory consulting firm that specializes in providing strategic FDA and global regulatory, quality and clinical research support to biotechnology companies. A seasoned regulatory executive, advisor and author, Kay has guided many organizations toward gaining FDA enforcement action resolutions, including those associated with FDA 483 Observations, Warning Letters and Consent Decrees. A frequent Regulatory Sciences guest speaker at UM and nationally, Kay was a member of the UM Coulter Translational Partnership Program Technical Oversight Committee and a founding member of the National NIH CTSA Regulatory Working Group IND/IDE Support Taskforce during her tenure at UM’s Medical School. Kay has held regulatory, quality, clinical and R&D positions of increasing responsibility with global medical device companies, including W. L. Gore & Associates, P-S Medical (acquired by Medtronic), C. R. Bard, Terumo Corporation, Cohera Medical, Tangent Medical and Rindex Medical. Kay is the primary inventor on two patents and received her undergraduate degree in Veterinary Technology from Texas State Technical College and is board certified in medical device and pharmaceutical regulatory affairs.

All session by Kay Fuller