rdm

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,

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.

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...

@ska, our development firm specializes in medical imaging software. A recent project involved a surgery navigation system. I know you are looking for on-site full time hires, but let me know if you would like to chat. My email is in my HN profile. (BTW if you are shooting for IEC 62304 compliance, you may want to checkout https://github.com/innolitics/rdm ; it isn't as polished as we would like, but we have a lot of interest in this tool)