I do not think, the "V" model is the only one that can be utilised for software development in order to create a medical device. Correct me, but in QSR nothing says that
Right.
WHY should be create another one documents for specification, which obviously will be a fake specification due to it will be created based on the test specification, or parallel with that
To be honest, I've never seen an SRS written from scratch. I experienced many cases but never the canonical theoretical V cycle.
The best case I 've experienced:
1st the developpers code something, it works! great! Let's do something we can sell!
2nd you or a guy do the risk analysis, write the SRS
3rd developers are not reluctant to write
and update a SDS, they modify the code to stick to specifications and risk mitigations
4th you or a guy writes the tests. They pass after a few iterations of bug fixes.
The worst case:
1st The developers code the whole thing. They didn't document anything and won't (they hate word processors, they think documentation is a loss of time, what the fork()!)
2nd You or another guy spend hard times doing the reverse engineering and writing SRS, SDS and tests. You play the role of fireman and do a risk analysis.
3rd At last, an "official" tests phase is organised, to ensure that risks are mitigated and what you wrote is what the software does.
So, no, I woudn't submit the software code to any agency. Design docs are made to give a broad view of the software. Reviewers won't analyse the code or I underestimate the time they can afford to a design file.
And I think I'm stuck to the R (like Realistic) cycle. Unless you're a tyranic project manager (a bad management for software development), developers code and you run behind them to ensure that what they do is what is required and that it is well documented.
Last word. Though borderline, this is only tolerable for software of low level of concern. Fortunately for high level of concern, I've only seen companies which can spend enough cash to do it the right way.
And I think I should buy a hat like yours. Perhaps developers would listen to me when I say their project lacks documentation!
Regards.