Validation of OTS (Off The Shelf) Software in Medical Devices

sagai

Quite Involved in Discussions
#11
We can write test scripts, we can have a whole custom built test environment to switch in the OTS and we can exhaustingly test it.
The only thing we can not have is unit tests for unknown software code. But it also only true if we consider unit as it was defined at the first place by the source code developer/architect. We can define our understanding about the units and their interaction and test it, no problem.
There are OTSs for algorithms, frameworks, plugins, codexs, etc. , OTS is not necessarily visible and recognizeble by the end user.
Actually In my understanding unit tests is up to the discretion of the manufacturer and not necessarily written for a device itself too.
 
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glork98

Involved In Discussions
#12
I see some classic crossing of "validation" and "verification" here.

In this case the validation is easy: It shows pictures your customers want to see and does it with mechanisms that comply with the requirements. (Select a file, run it forwards and backwards, etc.) The system testing validates the software.

The _verification_ is your Pandora's box. Does it work every time? Does it actually select the right file? Does it crash unexpectedly? Does it cause other software to crash? This is where you need to set up actual tests and exercise the software for typical uses and corner cases.

Check the standards and guidance as Sagai lists. You'll find it's very demanding to create a medical device that has any potential negative effect on patients or users.
 
L

Lulumathew

#13
Hi,

We are currently developing a medical system, in which one component is an android application.
In the context of OTSS validation, should we carry out validation for Android development environment and android OS?

Please advise..

Thanks
 
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