DHF/DMR/MDF for a software-only, cloud-based, single-instance device

SSchoepel

Involved In Discussions
#1
I looked at other posts and didn't find what I was looking for (please direct me if this has been addressed, I may not have had the right search terms).

For a software-only device, when there is a single-instance in the cloud, would you need to keep a DHF, DMR, and MDF for every revision or just the most current version because no user will ever be on an older version of the product?

I'm not asking because that's how we are doing it, it's just a thought I had and am wondering about the feasibility of having any one of those be able to be just the current product.
 
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yodon

Staff member
Super Moderator
#2
The DHF / MDF is a living document so, yes, all the updates would be captured.

The DMR idea doesn't exactly align with software. One could argue that build, archival, and deployment instructions could cover. What we normally do is include this in release documentation.

While there may only be a single instance in the cloud, you do need to archive old versions. I would recommend you take a look at IEC 62304 for release documentation, maintenance concepts, archiving, etc.
 

mihzago

Trusted Information Resource
#3
You need to retain records of previous releases in accordance with your document retention requirements, which are based on regulations that are typically different for each jurisdiction.

There's another record type you need to specify in the US, Device History Record (DHR). It contains things yodon mentioned such as build procedure, archive info, release notes, deployment checks, etc.
 
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