Rdm Alternatives
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InfluxDB
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WorkOS
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rdm reviews and mentions
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Ask HN: How do you keep track of software requirements and test them?
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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How We Develop AI for 510(k)-Cleared Devices
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...
Stats
innolitics/rdm is an open source project licensed under MIT License which is an OSI approved license.
The primary programming language of rdm is Python.
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