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FDA 510(k) Documentation Automation
by OMS Contributors
Description
Automates FDA-required documentation for Software as a Medical Device (SaMD) including 510(k) submissions. Generates traceability matrices linking code to regulatory requirements.
Version
1.0.0
License
MIT
Status
Coming Soon
Reviewer
Pending Review
Date Added
2026-03-02
Specialties
Regulatory Affairs Medical Devices
Tags
fda 510k regulatory medical-devices