Testing software-only device on hardware - What are the hardware parameters?

[SSchoepel]

Hello, I'm now working for a company that is developing a software-only medical device. I've only worked in places where there was also hardware/equipment. Our testing was always on a "production or production-equivalent system."

I realize we need to test on operating systems that we will support and that those will be on specific hardware. How do I say this without saying that we will have production-equivalent systems?

Can I say something about platform-equivalent systems and define what I mean by platform? Like Microsoft Windows 8 laptop, MacBook Pro running iOS 10.1.3, etc. Can I say that we have a minimum configuration on which it runs and test to that? "Minimum configuration-equivalent"?

Just wondering how others state and map to the test systems when it's software-only.

Thank you,
S Schoepel

 

[Stijloor]

A Quick Bump!

Can someone help?

Thank you very much!!

 

[SSchoepel]

This is what I came up with for our test plan and the hardware compatibility requirements will list the minimum system requirements for the platforms/computers/devices on which we will design the product to run:

[FONT=&quot]The testing is run on all supported hardware configurations (see the hardware compatibility requirements for the configurations) unless exceptions are indicated in this section.[/FONT]

I think it's sufficient.

Yes? No?

S. Schoepel

 

[michellemmm]

This is what I came up with for our test plan and the hardware compatibility requirements will list the minimum system requirements for the platforms/computers/devices on which we will design the product to run:

[FONT=&quot]The testing is run on all supported hardware configurations (see the hardware compatibility requirements for the configurations) unless exceptions are indicated in this section.[/FONT]

I think it's sufficient.

Yes? No?

S. Schoepel

I am a little confused. Are you trying to test hardware or are you testing integration of hardware and software?

 

[SSchoepel]

I am trying to test a software-only product on platforms/configurations that we will stated as being tested on/compatible with the software-only product. I've come from a "big iron" medical device company where we always tested on "production-equivalent" systems because we shipped a physical product. Not sure how to state properly what kind of test systems we are testing on for a software-only product.

Regards,
S. Schoepel

 

[yodon]

The first question I'd ask would be what happens if the system fails on a system on which it wasn't tested? What are the risks of not testing?

The second question I'd ask is what the spectrum of configurations looks like. If you can say that 90% of the population is anticipated to run on a set of configurations and there's no substantial risk for running on the others, maybe you test the 90%.

I know that systems deployed over browsers have the capability to know what browser (and maybe hardware configuration?) is being used so you could possibly prohibit use on untested configurations (or provide a pop-up saying, effectively, use at your own risk).

 

[c.mitch]

Hi Sschoepel,
I went through the same questions as yours when submitting PACS standalone software to the FDA. And I was also challenged by the developers team about FDA requirements.
I stumbled upon your posts and I felt less alone
About your questions on level of concern, I had the same problem. Minor a few years ago, FDA now "prefers" moderate for this kind of software.
About hardware/software platform compatibility, I went through different solutions: from freezing the configuration to having only minimum system requirements like those you mentioned.
Minimum requirements in the user/install instructions + tests on this configuration passed the exam of the FDA.
Now if you have web technology in your software, things get more complex. You'd better be more specific on the browsers you support and if your PACS viewer runs on smartphones/tablets (and I don't talk about cybersecurity and human factors engineering!)
A good source of information is to have a look at 510k summaries of your competitors. Eg: GE centricity universal viewer or zero footprint viewer. They're really intructive.

Anyway, Yodon's risk based approach is probably the best method to define rationale to stick to a configuration or to leave it open with minimum requirements.