Hi,

I´m currently working on (re) organizing and grouping our device requirements (Software and Hardware), and I´m curious as to how others have done this?

FDA´s design control exemplifies a grouping based on "Functional", "Performance" and "Interface" requirements. Does anyone have any opinions on how this grouping of requirements can be done?

By the way, I work in the Medical Device industry.


best regards
t.

Hopefully I'm not over-simplifying, but we start at a system level - could be a marketing requirements doc or more of a engineering level systems doc. From there, depending on complexity, we may then create separate requirements specifications for hardware, software, and/or consumables. That has worked for the bulk of the things we've developed. Given the nature of software, we have often further broken down software into application and user interface. When there are complex interfaces, we usually create interface specifications.

When the product is not so complex, we cover all aspects as appropriate in the system-level spec.

Typically, our top-level specs define performance requirements when they are applicable.

We use automated tools to trace between specifications in the hierarchy so we can show completeness (and subsequently show how each specification in the tree is verified).

Hopefully that helps. If not, let us know what you're specifically struggling with and maybe someone can offer additional advice.

Moved this thread to this section to get more responses.