Mobile Application which collects Physiological Data from a Medical Device

C

ConnieKeefe

I have a question , I suppose a ?mobile application which collect physiological data from medical device /wellness device, stores the data in its server, displays the data in its dashboard? can be considered as an MDDS, so if this application added with a feature of setting a high and low caution limits /goal settings (by a physician) can be still classified under MDDS?C4040-123 vce
Note : The application will not be used for real-time patient monitoring.
 
bio_subbu

bio_subbu

Super Moderator
ConnieKeefe said:
I have a question , I suppose a ?mobile application which collect physiological data from medical device /wellness device, stores the data in its server, displays the data in its dashboard? can be considered as an MDDS, so if this application added with a feature of setting a high and low caution limits /goal settings (by a physician) can be still classified under MDDS?C4040-123 vce
Note : The application will not be used for real-time patient monitoring.
Click to expand...

The same topic/question discussed in the existing thread "FDA guidance for MDDS, Medical Images Storage, Medical Image Communications", refer the post #5
 
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