This update addresses International and US National medical device standards ("a view of the landscape") being developed or revised that may be of interest to developers of software for medical devices or healthcare. Some of these standards are used directly for regulatory purposes and others may be valuable in demonstrating to regulatory authorities that a developer is using state of the art processes in the development of their products.
This table predicts how the standards being developed or revised will impact the development of health and medical device software. Early in the standard development this is an educated guess. As . . .
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