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SaMD Regulation: Navigating the FDA and EU LandscapeSoftware 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...0 Comments 0 Shares 1K Views 0 Reviews
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