SaMD Regulation: Navigating the FDA and EU Landscape

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2025-03-21 12:54:49 - Translate -

Software as a Medical Device (SaMD) is a category of software that, by itself, performs a medical purpose. This is distinct from software in a medical device, which is embedded within a hardware device. Here's a comprehensive look at SaMD content: 1. Defining SaMD: Standalone Functionality: SaMD operates independently of hardware, providing medical functions through...

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