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Software as a Medical Device

Foundations

Learn more about SaMD and how it will change the future of healthcare.

Medical implements and SaMD iconography on mobile device
Yena Lee
Kitty Makra
Yena Lee, Kitty Makra

What is Software as a Medical Device? A guide to building products & platforms at the speed of tech, not healthcare

Software as a medical device (SaMD) represents an opportunity to successfully build and launch patient-centric digital health products and platforms. In this article, we'll take you through the fundamentals: what is (and isn't) a SaMD, how federal and international agencies classify and regulate SaMD, and how you can get your digital health product to market faster.

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