Frantz Medical's Stephanie Harrington understands FDA medical device requirements

Stephanie Harrington, vice president of research and business development at Frantz Medical Development Ltd. in Mentor, Ohio, has plenty of experience navigating through Food and Drug Administration rules for medical device manufacturers. In a presentation at Plastics News' April 2010 Plastics in Medical Devices conference in Westlake, Ohio, she highlighted new developments, such as how the federal agency is considering changes to the 510(k) pre-market notification process it uses to review and clear certain medical devices marketed in the U.S.