Favorites ()
Apply

Georgiann Keyport

Adjunct Faculty

Regulatory Science & Medical Device Development

  • Education
  • ASQ Certified Biomedical Auditor (CBA)
    RAPS Fellow, FRAPS
    Regulatory Affairs Certification (RAC)
    MS, Laboratory Medicine, Immunology Concentration, University of Minnesota
    BS, Biology - College of St. Catherine, St. Paul MN

  • Research Interests
  • Regulatory Affairs, Quality Systems Clinical Research, Product Development, US and International Medical Product Regulatory Submissions, Pre-and Post-Regulatory Compliance, Regulatory and Clinical Strategy Development, Combination products, Biologics, Drugs, Medical Devices, Quality Systems Development and Compliance, Fermentation, Microbiology, Mammalian & Bacterial Cell Culture, Material Biocompatibility

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.