Our regulatory documentation manager. Streamlines 62304, 14971, and 510(k) documentation for software projects.
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Oct 27, 2022 - Python
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iso-14971
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python ai ml dicom segmentation radiotherapy medical-physics radiation-oncology iec-62304 pynetdicom radiation-physics radiation-therapy iso-14971 iso-13485 iec-62366
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Sep 9, 2023 - Python
FDA regulatory reviewer agents for Claude Code — 5 specialist personas for SaMD submission readiness, clinical safety, QMS compliance, cybersecurity, and human factors review
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May 3, 2026
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