Georgiann Keyport portrait

Georgiann Keyport

Adjunct Instructor
Office
OSS 228
Hours
By Appointment
Phone
952-994-8267
Mail
OSS 100
2115 Summit Ave
St. Paul MN 55105

Interests and Expertise 

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 

Career Highlights

Georgiann Keyport is a Senior Partner and co-founder of Canopy Medical LLC, a medical product consulting firm, where she has 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 Nova 510(k), IDE, Advisory Panels, Technical Files, Design Dossiers, 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. 

Education and Professional Affiliations 

B.S., Biology – College of St. Catherine, St. Paul MN

M.S., Laboratory MedicineImmunology Concentration, University of Minnesota 

Regulatory Affairs Certification (RAC) 

ASQ Certified Biomedical Auditor (CBA) 

Fall 2018 Courses

Fall 2018 Courses
Course - Section Title Days Time Location

J-Term 2019 Courses

J-Term 2019 Courses
Course - Section Title Days Time Location

Spring 2019 Courses

Spring 2019 Courses
Course - Section Title Days Time Location