Device FDA Inspections


Device FDA Inspections - Expert Tells All

Your office, Dec. 12, 2013

Your instructor

Jodi Scott, a Partner with Hogan Lovell focuses her practice on assisting the medical device industry in navigating the complex requirements for achieving U.S. marketing authorization and maintaining compliance to the FDA quality system and other postmarket regulatory requirements. Jodi assists companies in developing regulatory strategies and preparing product applications, including IDEs, 510(k)s, and PMAs; with compliance matters, including MDRs, recalls, and GMPs; in addressing regulatory due diligence issues; and with FDA training programs. Prior to joining Hogan Lovells, Jodi served for four years as senior FDA legal counsel and, subsequently, four years as principal FDA legal counsel for Medtronic, Inc., where she was instrumental in growing the company's corporate FDA legal practice to meet the needs of their business in an increasingly enforcement-minded environment.