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Product Description (JSON)

Regulatory Framework

  • HIPAA curated
  • FDA SaMD — 21 CFR Part 820 live eCFR
  • GDPR Health (Article 9) curated
  • 21 CFR Part 880 — Devices live eCFR

Live regulations are fetched from the official eCFR API at analysis time. Curated regulations use full official text where no live API exists.

Fetching regulation text and analyzing with Claude Sonnet...

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SOP-001

SOP-002

Analyzing both SOPs and generating proposed SOP with Claude Sonnet...