Georgiann Keyport is a Senior Advisor and founder of Canopy Regulatory Solutions Inc., a medical product consulting firm, where she had over 30 years of experience in the regulated medical device, biologic, and pharmaceutical industries as a scientist and in leadership roles in Regulatory & Clinical Affairs, Quality Systems, and Product Development.
Ms. Keyport has expertise in U.S. and international submission types, including Original PMA, PMA-S, 510(k), de Novo, 510(k), IDE, CTD application format, Advisory Panels, Technical Files, Design Dossiers, quality system development, post market surveillance, and post-approval submissions. Ms. Keyport has experience with combination products, medical device QSRs and pharma GMPs. She has international regulatory expertise in the European Union, Japan, Canada, and Australia.