How could we validate Team Foundation Server as our development tool to comply with IEC62304?

Question

We are using Team Foundation Server as source control, build agent and software development procedure control in our company. The question is that to comply with IEC62304 we have to validate it independently and prove that this tool is sturdy enough to be used. How could we validate it whether with another 3rd party software or in TFS itself?

Answer 1

Azure DevOps Server prior name Team Foundation Server (commonly abbreviated to TFS) is a Microsoft product that provides source code management (either with Team Foundation Version Control or Git), reporting, requirements management, project management (for both agile software development and waterfall teams), automated builds, lab management, testing and release management capabilities. It covers the entire application lifecycle, and enables DevOps capabilities.

TFS can be used as a back-end to numerous integrated development environments (IDEs) but is tailored for Microsoft Visual Studio and Eclipse on all platforms.

Not sure the detail meaning of "sturdy enough to be used" and how to verify this. But one thing is clearly, TFS could not validate it (IEC62304) in TFS itself. You may need help from 3rd-party independent agency or company to handle this.