Episode #36: Nidhi Gani: Championing Cybersecurity Regulatory Affairs

The seasoned regulatory affairs professional shares her experiences and insights

We sat down with an expert who has over a decade of experience in medical devices and digital health to discuss medical device security and AI.

About Nidhi Gani

Nidhi Gani is the Medical Device Cybersecurity Fellow Archimedes Center for Health Care and Medical Device Cybersecurity at Northeastern University. Nidhi is a seasoned Regulatory Affairs professional with over 10 years of experience in medical devices and digital health. Nidhi has worked with a diverse portfolio of devices ranging from heart and lung machines to rehabilitation devices to wearables. She currently also works as a Regulatory Affairs Software and Cybersecurity Lead at Embecta and teaches Graduate students Regulatory Product Development Strategy for Digital Health and Cybersecurity. Before that, at iCAD, she led the establishment of the Cybersecurity and Data Privacy program. Nidhi is passionate about human potential and loves to be at the intersection of cutting-edge technology and human health.