Real Skill packageSource verifiedClawHub registry

医械风险管理专家

医疗器械风险管理（ISO 14971:2019 / GB/T 42062-2022）专题技能——六步风险流程实操（风险分析→评价→控制→综合剩余风险→报告→生产后反馈）+ 危害识别清单 + 风险矩阵与可接受准则 + 风险管理报告框架。每份医械注册案卷的必备文件，审评首先看的"风险是否识别评价控制"，一站拿到可落地的模板与全球标准对照（含 FDA 认可共识标准、EU 协调标准、日本 JIS T 0304）。

Identity and source

Publisher attributionzhaoxinghua09-cellregistry owner unverified by skillvetai
Functional categoryAwaiting category reviewreview pending · 0% rule confidence
Package forminstruction with code10 recorded files
Canonical sourceClawHub registryclawhub:zhaoxinghua09-cell:medical-device-risk-management
Open canonical source ↗

Platform declarations

These states come from the source or distribution context. None of the entries below are SkillVetAI compatibility test results.

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/medical-device-risk-management

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/medical-device-risk-management

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/medical-device-risk-management

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/medical-device-risk-management
clawhub inspect @zhaoxinghua09-cell/medical-device-risk-management --version 1.0.0

Security evidence

SkillVetAI static result: high signal

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
9 / 10 inspected as text
Checked
8/27/2026, 10:18:59 PM
Scanner
0.1.3
Policy
1.0.3
1 automated finding
highRemote content is piped directly to a shell安全审计报告.md:28 · confidence 98%curl \| bash
1 High/Critical review queue entry
STATIC_DOWNLOAD_PIPE_TO_SHELLpending
Open human review queue →
3 inferred permission indicators
  • network access — automatically inferred
  • filesystem read — automatically inferred
  • filesystem write — automatically inferred
5 dependency and API indicators
  • api: clawhub.ai
  • api: health.ec.europa.eu
  • api: openstd.samr.gov.cn
  • api: www.fda.gov
  • api: www.iso.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, 4:17:54 PM
Release binding
Matches this record
  • vt: clean
  • skillspector: suspicious
  • 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:ebc78e010fc56590aab3eb286c4af0e7c68d8b3575b7feb951342a4eb99ed771
Show up to 10 recorded paths
  • ATTESTATION.md
  • LICENSE.md
  • manifest.json
  • medical-device-risk-management_security_test.py
  • references/风险管理知识库.md
  • security_results.json
  • security-radar.svg
  • skill-card.md
  • SKILL.md
  • 安全审计报告.md

Source changelog

首版发布：医疗器械合规专题技能，含 references 知识库 + 安全稳定性实测 + 权属证据包