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predetermined-change-control-plan

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mizcausevic-dev / fda-samd-classification-board

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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.

fda samd ai-safety de-novo healthtech pccp ai-governance 510k 21-cfr-820 kinetic-gain-protocol-suite predetermined-change-control-plan
  • Updated Jun 1, 2026
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