"FDA Regulatory Strategy"
Learn about the differing regulatory pathways for devices, therapeutics, diagnostics, and digital health technologies. We’ll review the many variables in cost and timeline and what they mean to you and your technology. Come ready with questions for featured speaker, Grace Powers.
Grace Powers is an independent regulatory affairs consultant. She founded Powers Regulatory Consulting in 2015 to help clients with regulatory strategies and submissions. Her clients have included universities, investors, start-ups and mid-size medical device companies. She has fifteen years of industry experience in medical devices including research and development. She has previously worked at Brookhaven Medical, Bard Medical, CardioMEMS and Novoste, all in the Atlanta area. She has leadership experience with managing regulatory affairs responsibilities related to all pre- and post- marketing regulatory activities and submissions. Her RA submission experience includes 510(k), Pre-Submissions, IDE, PMA, EU Technical Files and Design Dossiers. She has also managed an International RA team which including Canadian licensing, TGA, Japan, China, Russia, Latin America and other country submissions. Grace holds an BE in Biomedical Engineering from Vanderbilt University, an MS in Biomedical Engineering from UCLA and an MBA from Georgia Tech. She is RAC US, RAC Europe, and RAC Global certified.
The 2021-2022 Bench2Market Talks series which was created to provide commercialization guidance to the university research community. Click here for more details on the full series.