Software in Medical Devices, by MD101 Consulting

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FDA Draft Guidance on medical devices for home use

Too busy to write a long post this week.

I've not talked about a new FDA draft guidance yet:
The Draft Guidance for Industry and FDA Staff - Design Considerations for Devices Intended for Home Use.

Though not specific to software, this guidance has consequences on software design of medical devices for home use. The design team has to watch for problems linked to the users, their diseases and their environment where things can get messy.

Most of the content of that guidance is not intended to be applied specifically to software. But it contains a few elements that are applicable to software, mainly alarms, human factors, and use of device in emergency. That is another way of saying that ergonomics and human factors engineering are important input data for software development.

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