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BC medical-device-samd

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。

ClawHub Hermes author: zhaoxinghua09-cell v1.0.0 MIT-0 9 files body ≈ 574 tokens Open the sourceclawhub.ai↗ analyzed 3 d ago

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 +…

As a process C 53/100 · Has gaps — weak spots: result and completion, when it triggers, inputs and preconditions

ProcedureInfrastructuretype and topics are labelled automatically from the skill text
Runs in: OpenClaw Hermes Agent Cursor
JSON
Technical rating
B
83/100
safety, quality, tests
Safety 60%
95
Quality 40%
64
Run on models
none yet
Process rating
C
53/100
Has gaps
Result and completion w 14
0
Inputs and preconditions w 11
0
Failures and branches w 10
0
the three weakest of ten parameters · all ten

What is at stake

Medium-severity findings: the skill is probably honest, but read what alarmed the scanner.

Dangerous commands medium severity

Below is the worst case for this category. The finding here is medium: the guard saw a sign, not a proof.

If you install

The skill contains commands that delete files, rewrite disks or execute code fetched from the network. The agent may run them without asking if it believes the instructions require it.

For the author

Replace destructive commands with safe equivalents that ask for confirmation, scope them to one folder, and stop piping curl into a shell: pin a version and a checksum.

How to improve

  1. Say in the description WHEN to use the skill ("use when…", example requests): that is the agent's main cue.
  2. For Hermes the description must be one sentence under 60 characters; move the conditions to a "When to Use" section.
For the model run — optional
  • Your own cases (evals/evals.json, 4–6 real requests with expected answers): the full check would then run those instead of a model-drafted suite.
  • A spec.yaml with trigger phrases and assertions — a behaviour contract for CI; `skilltest init` writes a template.

Guard findings · 1

✓ No critical or high findings

Medium and low: 1
  • medium Dangerous commands cmd-pipe-to-shell 安全审计报告.md:28
    Downloads and executes remote code from an unrecognised host (pipe to shell) (documentation table row)
    | 远程脚本下载执行 | 无 `curl \| bash`、base64 解码执行等模式 | ✅ 无风险 |
    table

Files scanned: 9. Evidence is masked. Grey chips explain why severity was lowered.

Against the Agent Skills spec

  • warning description-long-hermes description is 246 chars; the Hermes authoring standard requires ≤ 60 (one sentence, ending with a period)
  • warning description-no-when neither description nor a "## When to Use" section says when to use the skill
  • note frontmatter-key unknown frontmatter key "displayName"
  • note frontmatter-key unknown frontmatter key "description_zh"
  • note frontmatter-key unknown frontmatter key "description_en"
  • note frontmatter-key unknown frontmatter key "xiaping_category"
  • note frontmatter-key unknown frontmatter key "xiaping_tags"
  • note frontmatter-key unknown frontmatter key "agent_created"
  • note frontmatter-key unknown frontmatter key "slug"
  • note frontmatter-key unknown frontmatter key "display_name"
  • note frontmatter-key unknown frontmatter key "title"

Process rating: all ten parameters 53/100

  • 0Result and completion. Does not say what the result is
  • 0Inputs and preconditions. Does not say what the process needs to start
  • 0Failures and branches. Linear process with no failure handling
  • 0Progress reporting. Says nothing while it works
  • 20When it triggers. No condition that starts the skill
  • 100Tools and files. No external tools needed
  • 100Steps. 24 steps
  • 100Consistency. Name and required fields are in place
  • 100Execution cost. Instruction body is 574 tokens
  • 100Running it twice. No mutating operations

Everything here is measured from the skill text rather than judged by a model, so the numbers are checkable. A parameter weighs more when it is a more common reason for the process to stall.

Quality signals

  • +5Description has no quoted example phrases that should trigger the skill
  • +4Description does not say when NOT to use the skill (false activations)
  • +3Output format is not stated: the model decides each time
  • +4No input/output examples
  • +2Single-language instructions
  • +3Description length 246: enough signal without eating the budget
  • +4Structure: 9 headings
  • +3Step-by-step instructions: 24 items
  • +4Reference files are cited in the instructions (1 of 1)
  • +1License stated

Quality base 70; lint remarks subtract, signals add up to 100. Result: 64.

External checks

ClawHub: clean
This is a coherent SaMD regulatory guidance skill, with a bundled local audit helper but no evidence of hidden runtime access, exfiltration, persistence, or unsafe automatic behavior.
LLM: benign (high) · VirusTotal: · 27 Aug 2026