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.
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.
yshrestha@innolitics.com