Sonali Dewan

Ms. Sonali Dewan brings over 20 years of global experience in the medical device industry, with leadership roles spanning Regulatory Affairs, Clinical Affairs, and Quality Assurance in both public and privately held companies. Prior to joining InspireMD, she served as Director of Regulatory Affairs at BlueRock Therapeutics, where she led global regulatory strategy for novel drug-device combination products across neurovascular, cardiovascular, and ophthalmic indications.

Before BlueRock, Ms. Dewan held senior regulatory leadership roles at Medtronic, Johnson & Johnson, Boston Scientific, and St. Jude Medical. Throughout her career, she has overseen the development and execution of global regulatory and clinical strategies for Class III and II medical devices, including neurovascular and cardiovascular devices, active implantables, remote monitoring systems, and software as a medical device (SaMD). She has successfully led FDA and international submissions—from early development through approval and commercialization—including PMA, IDE, and CE Mark submissions under EU MDR. Her strategic, business-driven approach has enabled market access for numerous innovative technologies in highly regulated markets.

Ms. Dewan began her regulatory career at Health Canada, where she served as a Licensing Officer, providing oversight and guidance to the medical device and pharmaceutical industries.

She holds a B.A.Sc. in Chemical Engineering from the University of Ottawa and a postgraduate certificate in Regulatory Affairs and Quality Operations from Seneca College. Ms. Dewan is Regulatory Affairs Certified (RAC) and a graduate of the RAPS Executive Development Program at the Kellogg School of Management.