GUIDE · DEVICE SOFTWARE AND AINEW
The next patient, the next update.
Software can never be tested on every path, and an AI model learns only from the data its makers chose. What evidence shows either will give the right answer for the next patient, and what keeps that true after an update?
Why software cannot be tested on every path, IEC 62304 with agile teams and pipelines, SOUP, OTS and the SBOM, how an AI model is trained, scored and watched, what a hospital must check before the first patient, cybersecurity, and what the FDA, the EU and India ask for before and after an update.
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