Elsa Abruzzo is President of the regulatory consulting firm, ARAC LLC, and has over twenty years of successful regulatory, quality, and clinical experience with innovative medical devices and disruptive biotechnologies, including embolic agents, stents, biomaterials, active implantables, and percutaneous heart valves. Elsa has worked with companies such as Baxter, Cordis Johnson and Johnson, CryoLife, Percutaneous Valve Technologies, AtriCure, Inc, InnerPulse, and Merlin MD. She has designed, developed and executed U.S.-based and international clinical trials, including Bayesian adaptive designs and break-through first-in-man studies. Elsa’s regulatory strategies have led to worldwide commercialization of products. Her clients, primarily startup and emerging growth companies, span the globe and a variety of medical disciplines. Elsa is Regulatory Affairs Certified and a RAPS Fellowfor the Class of 2010. She also has a BS in Engineering from the University of Miami and is a co-founder and co-host on Think Talk Radio on 55KRC in Cincinnati (55KRC.com or www.ThinkTalk Radio.com).