Whether software pre-installed inside the medical device is required to comply with IEC 25051

yodon said:

As far as I know, IEC 25051 is not recognized by anyone so you wouldn't get any leverage with regulatory bodies by complying with it (which is not to say that there isn't necessarily any value in complying with it). I'm not familiar with the standard, though, so what would it have you do differently than (just) 62304?thanks

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