Do I need a qualified compiler for class B software?

I am developing firmware for a medical device which fulfills the criteria for class B software.

The firmware is written in C and C++, for which some vendors provide toolchains that have certification for many standards, including IEC 62304 (e.g. Arm Compiler, IAR EWB). So far, we have used the free non-certified GNU Arm Embedded Toolchain for development. The certified versions are proprietary and quite expensive, so we would prefer to avoid their use. Furthermore, I have never, in two years of development, come across a compiler bug.

My question is: will it be necessary to use a qualified compiler/toolchain (or qualify the compiler ourselves), or can we use a non-qualified compiler?

I believe that it is not the case that we require a qualified compiler (i.e. we don't need any special considerations other than documenting its version and how it integrates with out build process and perhaps including compiler bugs as part of our risk analysis), and I found a blog post (unfortunately, I am not allowed to post links) that says that it is only necessary for class C devices, but I am not entirely certain and I am looking for some confirmation.


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By "qualified" do you mean putting it through something like IQ/OQ/PQ? If that's what you mean then, I don't subscribe to qualifying compilers. The software testing that you will do will provide far better assurance of functioning software than any kind of qualification protocol.

Of course, all this is predicated on the assumption that your internal procedures don't drive any specific qualification actions. And it's not a bad idea to double-check the manufacturer's specs to ensure you have an environment (OS, RAM, etc.) compatible with the tool.

You do want to "qualify" a toolchain for the target environment; i.e., choose a suitable one, preferably one that is commonly used (and those you mention certainly are)

A bit off topic, but there's a little less clarity on whether compilers / IDEs should be considered SOUP. It's my position that if you're using the libraries provided by the tool then there is certainly an element of SOUP. So in addition to just documenting its version, you should consider risks from unexpected results or failure of SOUP and evaluate the known anomalies with SOUP (these are applicable to Class B and C).
I suppose what I meant by "qualification" is any sort of process that would provide satisfactory assurance of the correctness and suitability of the compiler for regulatory compliance (such as compilation tests or compliance with e.g. IEC 62304 which the certified toolchains I mentioned provide).

The fact that you didn't mention these kind of tests or certification requirements, combined with the blog post I mentioned, puts me at ease with regard to the need for a certified toolchain. We will certainly include compiler errors in our risk analysis, although it seems like we should be able to assign them a very low probability.


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Aside from the excellent point about (SOUP) libraries provided by @yodon , there are only two areas involving compilers which would motivate some discussion 'above and beyond' simply detailing the compiler used:

1) Configuration management / Lifecycle concerns for your software: You may establish a configuration management plan that implies (or states) that you could reconstruct an executable (or the like) from source files. This by itself would not require validation of the complier, but it would require you to document and archive the compiler used to create the executable that was subjected to software system testing. Vendor toolkits have a habit of vaporizing; you may need to archive license keys as well as the compiler sources.

2) Unit / Integration testing: If white/gray-box testing of code relies on specific features of the compiler (e.g. comparing different outputs when different compiler switches are used), The compiler really ought to be treated as any other tool, and be qualified. Having written that, it will be nearly impossible (for most medical device companies) to validate certain aspects of a compiler, so if that path is taken (for the Medical Device Software testing) you shouldn't put too much weight behind such results. I think that it is generally possible to construct a comprehensive test plan such that if low-level testing relies on the compiler, it would be possible to establish higher level (System) tests that provide the necessary confidence that the Medical Device Software is working as necessary.
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