Meagan Fagan, M.S.

Ms. Fagan joined CardioMed in January 2019 as a Regulatory Consultant. Prior to consulting, she served as the Director of Technology for an innovative medical device company that specialized in the use of supercritical fluid technology to enhance drug delivery from drug-eluting implants (Class III medical devices). Her various roles within the organization allowed her a “hands on” approach from product/process feasibility, preclinical through FIH clinical trials to obtaining CE Mark and finally IDE approval. Ms. Fagan has over 12 years of experience in research/product development, design control and risk management along with preclinical device strategy and testing for combination medical device products, specifically drug-eluting stents. She has prepared pre-IDE and IDE submission materials and responses to interactive feedback with FDA; and drafted successful technical files that led to CE Mark approval.

Ms. Fagan earned her Master of Science degree in Chemistry from the University of North Carolina Charlotte and her Bachelor of Science degree in Chemistry with a minor in Biology from Mount Mary College. She is a member of the Regulatory Affairs Professional Society (RAPS).