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Contributed on September 1, 2021
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FDA Software Precertification: A Working Guide for Medical Device Companies 

Blog: Pathfinder Development

Recent years, we have seen digital health technologies moving toward rapid adoption in the United States. Yet, Software as a Medical Device (SaMD), mobile medical devices, digital therapeutics (DTx), and Device manufacturers with artificial intelligence (AI) components are often anxious about the lengthy and detailed process of the existing FDA’s premarket review for medical devices. […]

The post FDA Software Precertification: A Working Guide for Medical Device Companies  appeared first on Orthogonal.

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