Security News > 2023 > September > Championing cybersecurity regulatory affairs with Nidhi Gani

Nidhi Gani is a seasoned regulatory affairs professional with over a decade of experience in cybersecurity, medical devices, and digital health.

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.

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.

Nidhi said "Regulatory affairs is seen as an inhibition. But, if you use regulatory affairs strategically, they can be a very good catalyst towards your product development as well as regulatory approvals."

Harmonizing medical device cybersecurity standards is saving costs for manufacturers, but Nidhi stresses that there are greater questions about storing data and moving it across borders that must be addressed.

News URL

https://www.helpnetsecurity.com/2023/09/03/nidhi-gani-cybersecurity-regulatory-affairs/