Cloud-Based Stand Alone Software - Software Medical Device (Class II)

[SD1985]

Hi,

For a cloud-based stand alone software medical device (Class II), I was wondering how one would have DHR (Device History Records) as each user will have a user name and password to log on the same version of software which is hosted on the cloud. Each user would not get a CD or other physical device. Also, aside from deployment to the cloud, there would be no installation records...Any comments would be very helpful.

 

[yodon]

Yeah, the DHR model doesn't fit all that well with stand-alone software.

Per the regulation, the DMR is expected to contain:
* device specifications - should be easy enough to cite
* production process specifications - gets a bit gray here but what do you do to control the binaries after build and into installation? Do you also have specifications for the system on which the software is installed?
* QA procedures - consider a configuration status accounting audit
* Packaging and labeling - none other than some version ID in the software
* Installation procedures - should have them

Then, the DHR - the evidence that you followed the recipe (DMR) includes:
* date of manufacture
* quantity mfg & quantity released (will be 1)
* acceptance records - do you do any post-install checks?
* ID & labeling - should be your software version number
* device ID / control (UDI)

You could encapsulate all this in a version description document (that also points to information about your build process, development environment, build [configuration] info, etc.)

You wouldn't need to drill down to the individual user names.

You mention no installation records. Why not? The regulation does require a record. How do you know it was installed correctly? How do you know the platform is suitable for the software? Shouldn't need to be much but it should be easy enough to capture a record.

 

[SD1985]

Thank you, this was great info. When I stated installation records, I meant installation at customer sites. We will have deployment records (i.e., deploying the software to the cloud).