File Management system in Cloud for Medical Mobile Apps


Quite Involved in Discussions
I need some guidance for managing mobile medical apps, system config files in cloud, is there any guidance documents for managing DMR (i.e Master media set- Containing System Config file) in cloud for mobile app.

Any input/suggestion will be greatly appreciated.


Super Moderator
My immediate thought is to suggest you first ensure that your app needs to be managed as a medical device. Have you reviewed:

If it is a medical device and a DMR is required, then the regulation (21 CFR 820.181) defines what's expected:

And if it's an electronic record and/or electronically signed, then Part 11 compliance would be expected:

Note that a system config file would be considered a design output / part of the system that would need to be managed. You'd need to demonstrate that maintaining it in the cloud is secure and controlled.


Quite Involved in Discussions
Hi Yodon,

Thank you for your suggestion and guidance.

I have reviewed the Medical apps, and this product is an inventory dashboard so its not direct medical device application , its a management tool for supplies.

I strongly feel it should be Part 11 complaint and the design o/p requirements.

Thank you!
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