VIGILANT: Measurements for Adaptive AI
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Updated
Jun 8, 2026 - Python
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pccp
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FDA-Compliant Machine Learning Operations Pipeline — GMLP checklist automation, PCCP-ready model versioning, demographic bias monitoring, and drift detection
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Apr 8, 2026 - Python
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
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Aug 10, 2026 - JavaScript
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