Medical devices with touchgfx?

[aroni525]

Hello,

I really like the touchGFX framework. I am working in the startup company and we are developing the in-vitro medical device. One of our feature is LCD screen and I would like to build awesome and modern GUI for that purpose (gui's in medical looks often old-stylish).

The main problem is, all existing software (libraries, frameworks) are known as SOUP (software of unknown provenance) and there are restrictions of using such a software in the medical target. Since we have to comply with IEC62304 and FDA510(k) standards this may be a problem. I have not too much experience with standarization, that is why I want to ask if somebody has used this framework in critical and safety-related systems?

Probably there is not to many people doing such a things, so this question is directed rather to the developers of TouchGFX. Do you know some examples of application including TouchGFX? Maybe you can provide some extra resources (documentation, history files, tests) for an additional fee?

Thanks,

Arek

[Martin KJELDSEN]

Hi,

I've been involved in multiple medical device projects that have gotten FDA approvals for TouchGFX as SOUP (Respiratory and EEG). So that shouldn't be a problem.

I can't really share any information on those projects, i don't think. Is the above information enough?

/Martin

[jijomathew]

hi, 

is that possible to implement 300 screens which can be navigated through hardware pushbutton using touch gfx is there any referance 

 

[Martin KJELDSEN]

I can't really say, though, if these projects had to comply with the standardization codes you mentioned (IEC62304 and FDA510(k)

[aroni525]

Thank you for an answer. It means this is possible and I can go deeper into that.

I understand that you can't share informations about those products. But could you give me an advice how to manage this software. I mean, as there is some part of precompiled code I can't even create test cases od something like this, so it is not possible to verificate yours code.

I will need also some documentation probably, examples of medical devices where touchgfx was applied would be also good evidence for FDA and CE. Have you been involved in this subject, or you just know that somebody did that. Did you provided them some extra resources for certification purpose, or they get FDA approvals based only on their own documentation?

I apologize for such insight into details. I don't know how to handle this so I'm looking for some advice. I don't want that FDA ban my software because of SOUP...

If you don't want to share any info here, maybe some pw? =)

@Oh I didn't see your second message. If it's medical device thay haveto comply with this standards (FDA is more restrictive as I know). So your examples are good.

Arek

[Martin KJELDSEN]

These other projects did not have to provide that kind of data, i don't think. They managed to get FDA approvals, regardless. Isn't that what SOUP is for? You don't have to provide any tests, specifically.

I don't really understand how those verifications work - SOUP is weird to me. But, if it's a vital component you probably cannot run SOUP on the same MCU as your vital software. That's what they did on the Respiratory project while the EEG was pure measurement meaning it could run on the same chip as the medical software/algorithms.

/Martin

[aroni525]

Ok, thanks a lot for your help!

Now I know that it is worth to do this.

I don't understand it also... but we have to deal with it

Thanks again.

Arek

[Martin KJELDSEN]

No problem! Good luck :) Let me know how you do.

/Martin