Arti Tandon

Arti Tandon

Company: US Food & Drug Administration (FDA)

Job title: Digital Health Specialist, Digital Health Center of Excellence


Presentation: Addressing the Changing FDA Expectations Regarding the Development of SaMD, SiMD, AI & ML Devices to Enable the Production of Compliant & Innovative Software in the US 11:40 am

Discussing when the FDA Draft Guidance will be formalized and how it will align with the ISO standards Revealing how software developers can better understand what does and does not clarify as a medical device, how can developers identify if a 510k is required for the medical device and what exactly is required in this…Read more

day: Conference Day One

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