Real Skill packageSource verifiedClawHub registry

AI Medical Device Global Compliance（AI医疗器械全球合规）

AI/ML 医疗器械全球注册合规实操手册——覆盖美国FDA（510(k)/De Novo/PMA、PCCP预设变更控制、QMSR、网络安全SBOM）、欧盟（MDR Rule 11分类、AI Act高风险2028-08-02、CER/PMCF临床评价）、中国NMPA（分类界定、2026更新指南、变更注册、1000例数据本地化、创新通道）三地完整注册路径，含临床证据要求对比、变更管理与全生命周期（GMLP/算法漂移）、三地费用周期对比与并行出海策略。面向医械法规工程师、研发与国际业务负责人，附零依赖本地工具一键查询三地分类、路径、费用周期估算与变更触发判定。

Identity and source

Publisher attributionzhaoxinghua09-cellregistry owner unverified by skillvetai
Functional categoryEnterprise Functionsautomatically inferred · 60% rule confidence
Package forminstruction with code19 recorded files
Canonical sourceClawHub registryclawhub:zhaoxinghua09-cell:ai-medical-device-compliance
Open canonical source ↗

Platform declarations

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OpenClawnative officialProvenance: registry distribution

Independent structural checks

These checks parse the fixed package against dated platform rules. They do not execute the Skill or verify task behavior.

Claude Codepasses structure
Checker 0.1.0 · agent-skills-2026-08-13+claude-code-docs-2026-08-13 · 8/27/2026.claude/skills/ai-medical-device-compliance

Runtime, accounts, dependencies, permissions, network behavior and task quality remain untested.

OpenAI Codexpasses structure
Checker 0.1.0 · agent-skills-2026-08-13+codex-docs-2026-08-13 · 8/27/2026.agents/skills/ai-medical-device-compliance

Runtime, accounts, dependencies, permissions, network behavior and task quality remain untested.

OpenClawpasses structure
Checker 0.1.0 · agent-skills-2026-08-13+openclaw-docs-2026-08-13 · 8/27/2026skills/ai-medical-device-compliance

Runtime, accounts, dependencies, permissions, network behavior and task quality remain untested.

Installation and inspection

This command is recorded from the source ecosystem and resolves the registry's latest release. The fixed release shown on this page should be inspected before adoption.

clawhub install @zhaoxinghua09-cell/ai-medical-device-compliance
clawhub inspect @zhaoxinghua09-cell/ai-medical-device-compliance --version 1.0.0

Security evidence

SkillVetAI static result: no findings detected

This automated, non-executing scan is bound to this release hash. It is not a safety certification and may contain false positives or false negatives.

Status
completed
Coverage
full text content
Files
18 / 19 inspected as text
Checked
8/27/2026, 10:18:59 PM
Scanner
0.1.3
Policy
1.0.3
3 inferred permission indicators
  • shell execution — automatically inferred
  • network access — automatically inferred
  • filesystem write — automatically inferred
2 dependency and API indicators
  • api: clawhub.ai
  • api: www.w3.org
External clawhub result: clean

This is registry-supplied evidence for the recorded release, not an independent SkillVetAI scan. Check the canonical source for the full report, scanner versions, scope, and current moderation state.

Evidence checked
8/27/2026, 4:03:11 PM
Release binding
Matches this record
  • vt: clean
  • skillspector: clean
  • llm: clean

Recorded files

The catalog stores hashes and an inventory summary for change detection. It does not republish the package contents.

Package content hashsha256:c30ea4746b888ddb32e6fcf3277721e696726bfd6c874ca165871d76b8c3b153
Show up to 19 recorded paths
  • ATTESTATION.md
  • LICENSE.md
  • manifest.json
  • references/01-AI医械全景与定义.md
  • references/02-美国FDA注册路径.md
  • references/03-欧盟MDR与AIAct.md
  • references/04-中国NMPA注册路径.md
  • references/05-临床证据与数据要求.md
  • references/06-变更管理与全生命周期.md
  • references/07-三地对比与出海策略.md
  • references/08-术语表与FAQ.md
  • SECURITY_AUDIT.md
  • skill-card.md
  • SKILL.md
  • tools/ai_meddev_toolkit.py
  • verify/ai_meddev_quality_test.py
  • verify/gen_security_radar.py
  • verify/security_results.json
  • verify/security-radar.svg

Source changelog

v1.0.0: AI/ML medical device global regulatory compliance playbook - US FDA (510(k)/De Novo/PMA, PCCP, QMSR, SBOM), EU (MDR Rule 11, AI Act high-risk Aug 2028, CER/PMCF), China NMPA (classification, 2026 guidance update, change registration, 1,000-case data localisation, innovation channel); clinical evidence comparison, change management (GMLP/drift monitoring), cost and timeline comparison, parallel go-to-market strategy; includes 5-command local toolkit