Software Medical Devices without User Interface

A

andreiafilipaf

#1
Hi

How should the usability essential requirements be justified in a technical folder for a device that is a software without any type of user interface.
Take for example an embedded software that only calculates some type of output.

Thank you
Andreia
 
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mihzago

Trusted Information Resource
#2
IF the software is embedded then it is part of the medical device (hardware) and usability could be evaluated as part of the system.

If it's a stand-alone software, or even part of the hardware device, I imagine there is a Graphical User Interface. The GUI should be evaluated for human factors too e.g. size of text, numbers, colors; how the information is displayed (graphs, tables), how readable is it under various conditions, etc.

So, in case of a software that calculates output, how is this information displayed to the user. Who is the user, under what conditions is the information viewed/analyzed, etc.
 
A

andreiafilipaf

#3
In this case it is a stand-alone software but without GUI.
It is a module that works by it self: reads pictures of the eye from a pre-configured folder, processes the images and calculates some indicators that identify a disease. The output that the software produces is just a binary answer saying if there are signs of the disease or not. This output is written in a database.
The use of this output can then be done by any other tool independent to our software, that can retrieve the calculated value from the database.

So, at any time the user handles with our software, no GUI and my doubts on how to handle the usability requirements.

Thank you!!!
 

c.mitch

Quite Involved in Discussions
#4
Sounds like usability essential requirements are not applicable to you SW.
This is acceptable as long as there is a justification. And what you wrote in your post is probably a good one.
 

mihzago

Trusted Information Resource
#5
I agree with c.mitch.

I had a similar product I was supporting once. What I did, in the risk assessment for the software, which also included an analysis of the intended use, user/patient population, environment of use and other things (Application Specification); I added a section with a description and rationale that this software has no user interface and as such usability/human factors do not apply beyond the analysis conducted in the risk assessment.

This should be sufficient for a reviewer/auditor, and also shows you considered this.
 
O

obiwan612

#6
In my opinion every software, even the simplest one, has a minimum user interface.
For instance:
- how does the user start the module?
- how dooes the user stop it?
- how does the user monitor that the module is running and working properly?

So in my opinion, even in the simplest scenario, a minimal usability analysis shall be performed.
 
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