Agile Development For Medical Device Software: Is It Possible?

This is the million-dollar question, or the Holy Grail of medical device compliance: Can you do agile development which magically generates all the necessary compliance documentation for your audits?

I'll walk you through what's needed for passing audits, and based on a typical agile development process (ours!), we can take a look at whether it's possible.

Link to Formwork:

[brunomarques]

Thanks for your videos! I'm new to this kind of regulatory documentation, but your content helps me out a lot :)
I'm just curious about the conclusion here:
Obviously, your video points out that shipping your Jira/trello/whatever tickets / Github issues & PR discussions etc. as documentation for your medical software is not an option.
But both can still be done in parallel right? an Agile board / issue tracker for developers, and the documentation for regulation.

I mean taking your example here, a milestone could be added to the basecamp ticket, and the output of that ticket would not only be to perform the change in the software, but also to update the documentation accordingly..?
In a previous project, each issue had a checklist that needed to be fulfilled for that particular issue to be closed:
1. Provide possible solutions + chosen solution for the fix
2. Implement the fix
3. Provide 100% test coverage
4. Update project requirements

Then the next release in which the fix is implemented matches the project documentation.
Would this workflow work?