Real Skill packageSource verifiedClawHub registry

SaMD软件医疗器械专家

SaMD（Software as a Medical Device）软件即医疗器械专题技能——SaMD 判定与 IMDRF N12 风险分类（I-IV 类）+ IEC 62304 软件生命周期（A/B/C 级）+ FDA 软件三级关注（Major/Moderate/Minor）+ MDR 软件分类规则 11 + 网络安全（MDCG 2019-16、FDA 网络安全指南、SBOM）评估清单。独立软件/含软件器械注册申报的软件文档怎么搭、分类怎么定、网络安全怎么做，一站理清，附官方入口直达。

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-samd
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-samd

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-samd

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-samd

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-samd
clawhub inspect @zhaoxinghua09-cell/medical-device-samd --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: www.cmde.org.cn
  • api: www.fda.gov
  • api: www.imdrf.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, 4:24:37 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 hashsha256:4c80c3df127033d1e85747cdc6dd2d6199cb7fa83363136d489db9d197f0a38b
Show up to 10 recorded paths
  • ATTESTATION.md
  • LICENSE.md
  • manifest.json
  • medical-device-samd_security_test.py
  • references/SaMD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