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.
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.