Nidha Gani Daniel Young 5 September 2023

Hello, I'm Nidhi...

As the phrase goes ‘From bench top to bed side’, research and approval of the products are both inter-related. I believe that being on the bed side is directly involved with the betterment of life.
Nidhi is a seasoned Regulatory Affairs professional with over 10 years of experience in medical devices and digital health.
Being able to participate in the journey of the product from it's inception to the market motivates Nidhi.

Nidhi Gani, Medical Device Cybersecurity Fellow Archimedes Center for Health Care and Medical Device Cybersecurity at Northeastern University.

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.

As a Regulatory Affairs Professional, its her mission is to help the healthcare industries develop safe and effective products.

Nidhi is passionate about human potential and loves to be at the intersection of cutting-edge technology and human health.

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Have regulatory questions? Need a better idea of how to manage security requirements under HIPAA or GDPR? Let’s find a time to talk.

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