Conducting a Seminar on FDA Regulatory Guidance for Software as a Medical Device (SaMD)

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Event Info:

7th Sep 2023

10:00 am - 03:00 pm

Venue:

Bengaluru, India

On 7th September, the IKP Global Regulatory Forum (IGRF) conducted a seminar on ‘FDA Regulatory Guidance for Software as a Medical Device (SaMD)’ at IKP EDEN. The featured speaker was Mr. Bakul Patel, Senior Director of Global Digital Health Strategy and Regulatory at Google. He is credited with coining the term ‘Software as a Medical Device,’ and has notably constructed a robust risk framework for software in the medical device context.

The in-person meeting was attended by 25 digital health start-ups, where they were guided on the planning and development of implementation
strategy for getting FDA approvals.

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