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Mona Advani, M.Sc., MBA

Principal Regulatory Consultant
CardioMed Device Consultants
HERNDON, Virginia, United States

Mona Advani is a recognized Medical Device Consultant with 23 years of professional experience in domestic and international regulatory affairs with a focus on FDA, Software, Digital Health, Cardiovascular, Neurovascular, and Clinical Study design. She has served as a Regulatory Consultant for a wide range of technology devices, previously holding titles of Senior Director of Regulatory Affairs and Clinical Research, Manager of Business Development, Manager of U.S. and International Regulatory Affairs. Mona has worked with small and large medical device companies, successfully focusing on the appropriate product development strategy both in the United States and internationally, including the European Union (EU), Japan and Canada.

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