> Regulatory requirements usually does box you into a waterfall sdlc.
This really isn't true, at least not for this context.
This really isn't true, at least not for this context.
As far as regulatory submissions go and the design outputs that get stored in your QMS, the SDLC appears waterfall because there are clearly defined design inputs, design outputs, and verification / validation checkpoints. In practice, however, the actual process can be agile.
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.