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510k

Here are 3 public repositories matching this topic...

mizcausevic-dev / fda-samd-classification-board

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
JavaScript

RAPath / rapath.github.io

RAPath Global Hub - Medical Device Regulatory Reference in Plain English. Properly sourced.

tga fda samd medical-device mdr udi regulatory-affairs regulatory-compliance 510k ivdr mhra health-canada ce-marking medical-device-regulation

Updated Jun 3, 2026
TypeScript

Leon-SG / awesome-medical-device-regulation

A curated list of resources for medical device regulatory professionals — agencies, standards, databases, tools, and educational content.

fda awesome-list medtech regulatory regulatory-affairs medical-devices regulatory-intelligence pmda 510k eu-mdr ce-marking medical-device-regulation

Updated May 13, 2026

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