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de-novo

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Hash-chained, append-only record schema + reference verifier for an AI/ML medical device's FDA SaMD classification lifecycle, pre-submission through 510(k)/De Novo/PMA, PCCP per FDA Dec 2024 final, post-market modifications, 21 CFR §820 QMS evidence refs. Healthcare-readiness scaffolding, not certification.

  • Updated Aug 10, 2026
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