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Thu, Jul 25

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Virtual Event

Regulatory Roadmap Discovery

The presentation will cover the differences between wellness, Class I 510(K) exempt, and Class II devices for digital health, digital therapeutics, health tech, and medical devices and introduce an example of regulatory roadmap for early-stage startups.

Regulatory Roadmap Discovery
Regulatory Roadmap Discovery

Time & Location

Jul 25, 2024, 12:00 PM – 1:00 PM

Virtual Event

About the event

Marcella Garcia specializes in building early-stage medical device & digital health startups with a focus on regulatory strategy, quality, and information security - with over ten years working at the executive level in Class I/II/III complex electro-mechanical medical devices, SaMD, digital therapeutics, AI/ML,

IVD, control systems, and electronic diagnostic hardware and over twenty years working with complex technologies, integration, and operational excellence.

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