Review/Recommendations: requirements management tools/software


Involved In Discussions
Based on my experience, and being on various courses and seminars, it's definitely advantageous to use a "proper" requirements management tool/software to avoid excel hell (I also see several annotations I've made on courses underling try to avoid word based documents, even though that's what I've seen often in practice).

Does anyone know of some good examples of tools for this that are well suited to MDR/IVDR MDSW?

And I'm still not super confident in how to argue back to a developer who tells me that DevOps can do all this already, I mean in practical terms what kinds of arguments are valid, like
"DevOps doesn't do THIS very good" or "managing THIS in DevOps will become a problem".

Sorry for some slight overlap to previous question about dev tools; I just realised that most of my experience relating to projects using (mostly Github) I've only ever seen things like anomaly lists/issues and unit documentation there, everything else, risk analyses, requirements and traceability outside "developers world" and in a QA controlled QMS documentation system.


Super Moderator
I don't know DevOps capabilities but you can always ask a developer to demonstrate. Software requirements need to trace up to a parent requirement (usually either a system requirement or risk control), into the architecture, and down to tests where they are verified. If they can show you how that's accomplished, let 'em have it!

IBM DOORS is one tool but it's expensive, requires a considerable amount of overhead to set up and maintain, and is kind of wonky when it comes to deliverables. I used Siemens (?) Polarion but had a difficult time getting developer buy-in. (There used to be a tool called Rational ReqPro that we all here thought was ideal but IBM bought it up and DOORS swallowed it. Polarion is somewhat like ReqPro but not as use friendly.) I think many eQMS systems bundle in some form of requirements trace management capability but that may be way more than you need. Unfortunately, I don't know of any magic bullets.
Top Bottom