Nidhi Gani is a seasoned regulatory affairs professional with over a decade of experience in cybersecurity, medical devices, and digital health. She’s worked with devices ranging from heart and lung machines to rehabilitation devices. Nidhi works at Embecta as a Regulatory Affairs Software and Cybersecurity and is a Cybersecurity Fellow at the Archimedes Center for Health Care and Medical Device Cybersecurity at Northeastern University. She joined the Left to Our Own Devices podcast to share her experiences and her insights.
The world of regulatory affairs for medical device manufacturers has undergone a seismic shift in recent years as regulators demand more reliability and transparency from medical device manufacturers– especially surrounding their cybersecurity.
On the podcast, Nidhi Gani explained how she came to the US to continue her studies in biology and immunology and discovered regulatory affairs along the way. As she learned more about the greater medical ecosystem, she discovered her calling in this growing niche that would help companies reach the market with less regulator friction.
Regulatory Affairs as a strategic partner
In the earlier years of…
