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dearauditor-qms-baseline

AliakseiT / dearauditor-qms-baseline

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Open-source, GitHub-native eQMS baseline for medical device and regulated software teams. Issues, PRs, Actions, and Releases form the quality system of record. Covers ISO 9001, ISO 13485, ISO 14971, IEC 62304, IEC 62366-1, ISO/IEC 27001, ISO/IEC 42001, GDPR/nFADP, plus an optional GAMP 5 / 21 CFR Part 11 overlay.

compliance samd qms quality-management iec-62304 iso-27001 iso-14971 iso-13485 iso-9001 medical-devices capa digital-health regulatory-compliance quality-management-system gamp5 eqms iso-42001 21-cfr-part-11
  • Updated Oct 28, 2026
  • Python

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