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rdm
Our regulatory documentation manager. Streamlines 62304, 14971, and 510(k) documentation for software projects. (by innolitics)
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WorkOS
The modern identity platform for B2B SaaS. The APIs are flexible and easy-to-use, supporting authentication, user identity, and complex enterprise features like SSO and SCIM provisioning.
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...
NOTE:
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Hence, a higher number means a more popular project.
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