rdm VS MkDocs

Been working as a consultant and engineer on FDA regulated software for about 8 years now. I have seen strategies from startups to huge companies.

I have seen requirements captured in markdown files, spreadsheets, ticket management systems like Redmine, Pivotal, Jira, GitLab, Azure Devops, GitHub Issues, and home grown systems.

If I had to start a new medical device from scratch today, I would use Notion + https://github.com/innolitics/rdm to capture user needs, requirements, risks, and test cases. Let me know if there is interest and I can make some Notion templates public. I think the ability to easily edit relations without having to use IDs is nice. And the API makes it possible to dump it all to yaml, version control and generate documentation for e-signature when you need it. Add on top of that an easy place to author documentation, non-software engineer interoperability, discoverable SOPs, granular permissions, and I think you have a winning combination.

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We've had somewhat of a hard time applying agile to IEC 62304, although it's not impossible.

This document has some useful tips:

AAMI TIR45:2012 (R2018) Guidance On The Use Of AGILE Practices In The Development Of Medical Device Software

Also, we have an open source offering that includes an IEC62304 compliant software plan. You can check this out here:

https://github.com/innolitics/rdm/blob/master/rdm/init_files...

MkDocs is BSD-2-Clause licensed and has a vibrant community; GitHub Discussion is used for questions and high-level discussion, while the Gitter/Matrix chat room is used to discuss less complex topics. These communities provide essential resources and support.

MkDocs is a fast, simple and downright gorgeous static site generator that’s geared towards building project documentation. Documentation source files are written in Markdown, and configured with a single YAML configuration file.

MkDocs is a popular static site generator designed explicitly for building project documentation. Its minimalist approach, flexibility, and ease of use have made it a favorite among developers and ideal for non-technical users.

MkDocs is a popular static site generator specifically designed for project documentation. It is built on Python's Markdown processing engine and comes with a clean and responsive default theme. MkDocs is easy to configure, and its simplicity makes it an excellent choice for quickly creating documentation for your projects.

Take a look at https://www.mkdocs.org

I was thinking about using MkDocs, its usually used for documentation but I don't see why it couldn't be used for a normal wiki aswell. Since It's markdown you can just customize it like if it were a wiki, and a wiki doesn't really need backend stuff so I don't see a problem with it