[jdgiese]

We use a very similar approach at Innolitics when working on medical-device projects for our clients. We've been slowly creating an open source tool to help streamline all of this (https://github.com/innolitics/rdm). We've used this tool to write 510(k)s for three of our clients now and have a couple of more submissions in progress. Each time we go through it we improve the tool a bit.

It handles requirements gathering, documentation generation, regulatory audits, and design documents. We also have been playing around with Structurizr DSL and so far like it quite a bit. We also have a backend that integrates with GitHub and plan to add backends for GitLab and Jira soon.