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Software requirement and design specifications - Medical device contains both hardware and software


Hey guys,

If your medical device contain both hardware and software, do you combine the specifications for both hardware and software in one document or do you keep them separate? FDA guidance and IEC 62304 calls out for creating SRS and SDS documents for the software. I am not sure if I should combine hardware specifications in there as well.


Staff member
Super Moderator
Nothing requires you to have them in separate documents - just do whatever makes best sense for you. If you don't segregate them physically, be sure to somehow identify them so it can be readily understood is a software requirement and what isn't. This can be manually facilitated through naming /unique ID conventions. If you use a requirements management tool, this can be accomplished using attributes.

Also consider maintainability. Software requirements tend to be updated more frequently. It might be easier to keep them separate to keep the 'churn' isolated.
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