Oh, I see what you mean, and yes I agree. I would word it differently, that the set of documents in your DHF, MDR, 510(k) filing, etc. are identical regardless

Oh, I see what you mean, and yes I agree. I would word it differently, that the set of documents in your DHF, MDR, 510(k) filing, etc. are identical regardless of the methodology you use to create them. Some of the language around them sounds "waterfall-y" but you are perfectly welcome to iterate on these documents. The documents themselves are more about engineering practice than process, and are an output of whatever process you use, much like the software is.