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stevenzhao07/README.md

Xinghua Zhao · 赵兴华 — Medical-Device RA & AI Governance

Open-source, zero-dependency tooling for the full lifecycle of medical-device AI, organised as a plugin matrix on LGD — a declarative, industry-neutral skeleton in which every capability is an independently loadable module. Medical devices are the reference domain; the skeleton itself is industry-neutral and extensible to AI agents, cybersecurity and other verticals.

Focus: open-source tooling for medical-device regulatory affairs & AI governance, published as an individual project by @stevenzhao07. Pure technical input, no commercial promotion.


🧭 Core entry point

  • medical-ai-toolkit — the single navigation portal. It auto-discovers and routes all modules; start here.

🗂 Project categories

Repository count verified via GitHub API on 2026-10-13: 25 public repositories under @stevenzhao07. (The portal README's older "21-repo" figure is outdated and is being corrected in a pending portal PR.)

Category Repositories
Portal / profile medical-ai-toolkit · stevenzhao07 (this repo)
AI governance & trust methodology ai-a3-laws · ai-governance-checklist · ai-model-passport · delivery-guard
Medical-device lifecycle (QMS / RA) design-controls-toolkit · device-regulatory-map · iec62304-software · iso14971-risk-file · manufacturing-gmp · clinical-evaluation · biocompatibility-iso10993 · sterilization-validation · pms-vigilance · udi-assignment · cybersecurity-medical
AI / ML tooling ml-validation-toolkit · samd-ra-toolkit
Interop / data / labeling fhir-ortho-toolkit · omop-ortho-toolkit · multilingual-ifu
Cross-domain / ecosystem silent-failure-catalog · uibc-core · awesome-healthcare-agents

🤝 How to contribute

  • Read the Contributing Guide (hosted in the portal).
  • Pick a task from Good First Issues if you are new.
  • Open an Issue or PR against the relevant repository. Every change goes through a branch + pull request; nothing is merged to main without review.
  • Report security or regulatory-accuracy concerns via the portal's Security policy.

✅ Verification status — honest convention

We separate four distinct levels and never conflate them (the full convention is documented in the project's attribution note, pending a separate PR):

Tier Meaning Current state (2026-10-13)
🟢 CI Automated checks pass in GitHub Actions medical-ai-toolkit harness green (last success 2026-10-13 02:55Z; earlier runs same day failed — see portal PR notes)
🟡 Functional self-test Module ships a runnable self-test Partial — most CLI modules include a self-test path; coverage varies per module
🔵 Expert review Domain-expert sign-off Pending — these are reference implementations, not clinically validated
⚪ Official source verification Regulatory constants traced to a dated official source Partial — where annotated (e.g. GMP 2025 #107 verified 2026-10-12); others marked "verify before use"

⚠️ Nothing here is a medical device, a certified regulatory submission, or clinical advice. Tools output decision-support references; users remain responsible for confirming against current official texts.

📄 License

Declared intent: code primarily Apache-2.0, documentation/content under CC BY 4.0 (some reference texts CC0), where a LICENSE file is present. Across the account, licenses are mixed per repository (Apache-2.0 / CC BY 4.0 / CC0 / MIT) — see each repo's LICENSE. A LICENSE file for this profile repo is pending owner approval (deferred); until filed, the license here is proposed, not yet final.

🔗 Related / associated accounts

Some repositories originate from or are mirrored with the associated account @zhaoxinghua09-cell (e.g. uibc-core, silent-failure-catalog, awesome-healthcare-agents). They are listed here for discoverability but their upstream ownership is noted in each repo's own README.

🤖 Attribution & AI assistance

This account and its documentation were produced with AI assistance. The specification for the account reorganisation was drafted with ChatGPT and reviewed by the account owner; execution was performed by a WorkBuddy agent on the owner's machine. AI is assistive only and does not replace domain-expert review or official-source verification. (Full dated disclosure — author, AI-assistance, license, contributor credit, verification convention — is pending a separate PR.)


Maintained by @stevenzhao07 · Last layout update: 2026-10-13.

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  1. uibc-core uibc-core Public archive

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    UIBC Core — an executable protocol for bounded-lifecycle autonomy:registry, evidence, gates. Reference implementation + conformance tests. Theory SSOT: zhaoxinghua09-cell/lgd-theory. 代码 Apache-2.0;…

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