innolitics/rdm
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Our regulatory documentation manager. Streamlines 62304, 14971, and 510(k) documentation for software projects.
4 mentions on Hacker News by 2 people: 0 stories, 4 comments · first 2020-04-01 · latest 2022-04-20
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…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…
comment by yshrestha · 2022-04-20 · in Ask HN: How do you keep track of software requirements and test them? -
…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…
comment by jdgiese · 2021-06-24 · in Ask HN: What software do you use to gather requirements? -
…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...
comment by jdgiese · 2021-02-01 · in How we develop FDA-compliant machine learning algorithms -
…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)
comment by jdgiese · 2020-04-01 · in Ask HN: Who is hiring? (April 2020)