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Medical Device Software - Is a Help Button required?

MDD_QNA

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#1
#1
Is there a requirement to have the Help Button in the software for a class IIb medical device? If yes, where can i find the requirement?
 
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#2
#2
Software in a medical device could be completely 'embedded'; in such cases a 'Help button' would be meaningless.

It is conceivable that a 'Help' menu could be identified in the design as a risk control (presumably around usability), or could be implemented as a mechanism for distributing information. I am not aware of any standard or regulation which requires such a thing.
 
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