Medical Device Smartphone App Regulatory Requirement and Labeling

R

robertjbeck

#1
in a typical user manual for a medical device, there are tables of regulatory information such as symbols, operating temperatures, cautions, warnings, compliance to various standards such as 60601-1, 60601-1-2, and so on.

for a Smartphone App that is part of medical device, what are the required contents? is it ok to have a button that brings up screens containing this information or should it be structured so that it cannot be avoided, like a EULA?
 
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mihzago

Trusted Information Resource
#2
you don't have to force the user to see it. As long as they can easily access it, you should be fine. I usually create an About menu/screen which contains the name of the device, company name, address and contact info, symbols (CE, EC-REP, Rx, etc.), intended use statement, warnings, cautions.

This information is also included in a user manual.
 
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