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Active devices - software and programmed devices
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There are classification rules that apply to active medical devices that are:
- software (including Software as a Medical Device)
- programmed
- programmable.
The terms ‘programmed’ or ‘programmable’ are intended to capture hardware active medical devices incorporating software or any other form of software-type instruction set (such as field programmable gate arrays).
Question
Is your active medical device (or any of its components) software, programmed, or programmable?