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Software Requirements Review

Our requirements are done. But we are not quite done yet. We need to review those requirements.

Let's have a look at our software development process and where software requirement review comes in.

I'll also answer the question why we have to review software requirements while trying not to rant too much.

Next, we'll see how to actually review software requirements by using the OpenRegulatory checklist.

While filling out the checklist, I'll notice that we're lacking traceability to design input so we'll quickly fix that by going back to the software requirements list. This also answers the general question how to create traceability from (ISO 13485) design input to software requirements.

Finally, we'll go through the items in the checklist. I'll also briefly talk about when to write tests for your software requirements.