Is STM32CubeIDE certified for developing medical device software?

[ACapp.1]

IAR Workbench has this:

https://www.iar.com/iar-embedded-workbench/certified-tools-for-functional-safety/.

and they assert compliance with IEC 62304.

Of course it's good to comply with development standards when making the development tools themselves, but can anyone think of a situation in which this certification would be required?

If such a situation exits and applies to the device I'm working on, I'm sure my company would be willing to pay for a certified version of STM32CubeIDE. Does this exist, or are there any plans for a certified edition in the future?

--AndyC

[Tesla DeLorean]

Have you seen forum traffic on these Cube softwares?

Realistically if you want safety as a priority you're going to have to pay for professional software, from the likes of Green Hills, IAR or Keil.

http://www2.keil.com/mdk5/safety

[ACapp.1]

Safety is always a priority, but does having this certification make the system any safer?

The real question is whether it is actually required - it costs money that might spent on additional features or testing.

This certification covers the standard C libraries, (e.g. stdlib.h, math.h, etc) so we wouldn't be required to identify them as SOUP components, but we use other things that do have to be identified as such and it is just a question of whether that is an acceptable risk. For example if your device is running Linux there is no practical way to certify it but that doesn't make it unsafe compared to writing your own OS.

[Tesla DeLorean]

The aforementioned companies spend a lot more time/effort to build/test their tools/libraries to meet stringent requirements.

The GNU/GCC tools are generally a lot more lackadaisical and amateurish in their approach. If you're willing to own the testing and validation tasks, that's fine too, but expect it to be something you have to repeat often and thoroughly.

[Pavel A.]

In other words: Linux and GNU are good for job safety for those who do testing and validation 😉

-- pa

[Herve PIERROT]

So far, there is no plan for our own tools to have safety certification. We rely for that on our usual partners listed above. Nevertheless, for the libraries, you can have access to specific libs certified for the IEC 61508, the industrial safety certification (https://www.st.com/en/embedded-software/x-cube-stl.html).

But even for those, there is no plan yet to go further with the IEC 62304.