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Contributed on July 22, 2019
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FDA Software Precertification: A Working Guide for Medical Device Companies 

Blog: Pathfinder Development

The Food & Drug Administration’s Software Precertification Program represents a fundamental paradigm shift in the regulation of medical device software. Launched in 2017, the program can be thought of as the FDA’s response to an increasingly complex, evolving ecosystem of digital health, as well as the fast-paced technological innovation that has been driving change across […]

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

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