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January 26, 2016
26
Jan

FDA draft guidance Interoperable Devices

January 26, 2016
NOTE: This is for historical reference as a final guidance was issued Sept 2017 and is posted separately. FDA issued a new draft guidance entitled “Design Considerations and Pre- market Submission Recommendations for Interoperable Medical Devices”. This guidance addresses medical devices that exchange information whether wired or wireless including through the internet. It includes unidirectional...
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IEC 29119-1 Software and System Testing

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IEC 62366 Usability Process and Documentation

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