This a great opportunity to quickly expand your network with a burgeoning MedTech ecosystem and participate in a lively discussion with an engaging audience. The format of the discussion is fairly informal with discussions centered around 3 regulatory themes (Regulatory Strategy, Engaging with the FDA, and EU MDR and/or EUA related questions) with 2 SMEs. A facilitator will ask a question around each of these themes to get a discussion started with the SMEs and the floor subsequently is open for participants to ask follow-up questions. We typically have around 8-12 participants for any given meeting.
Grace Powers is an independent regulatory affairs consultant. She founded Powers Regulatory Consulting in 2017 to help clients with regulatory strategies and submissions. Her clients have included universities, investors, start-ups and mid-size medical device companies. She has eighteen 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.
Mindy McCann has broad and multi-faceted experience in medical device international regulatory affairs and quality management, having worked for a start-up, large global company and two notified bodies, before joining Qserve, a medical device consulting company. Mindy’s enthusiasm for regulatory compliance, communication skills and leadership skills make her an effective project manager and engaging trainer. Mindy’s hands-on experience as a development engineer, notified body auditor and technical file reviewer, global certification manager, and regulatory and business executive has led to a practical approach in developing and implementing regulatory strategies and quality procedures; auditing; and writing and reviewing clinical evaluation reports, technical documentation, and clinical investigation protocols and applications.
Agenda is as follows:
- 20 intro for SMEs and round table participants
- 60 min for discussion (15-20 min / theme)
- 10 min for closing remarks