Meagan Fagan is a Principal Consultant at CardioMed Device Consultants, bringing more than 19 years of experience in medical device development, regulatory affairs, design controls, and preclinical testing. She specializes in complex Class II and Class III medical devices, particularly drug-device combination products, and provides regulatory and technical guidance from early product development through clinical investigations and regulatory submissions.
Experience
Since joining CardioMed in 2019, Ms. Fagan has supported medical device manufacturers in developing regulatory strategies, preparing FDA Pre-Submission and Investigational Device Exemption (IDE) submissions, addressing FDA feedback, and planning preclinical testing and verification and validation programs.
Previously, she served as Director of Technology at a medical device company specializing in drug-eluting implants. Her experience spans product feasibility, design and development, preclinical testing, first-in-human clinical trials, FDA IDE approval, and CE Mark certification.