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CC risk-management-specialist

Medical device risk management specialist implementing ISO 14971 throughout product lifecycle. Provides risk analysis, risk evaluation, risk control, and post-production information analysis.

borghei/Claude-Skills Agent Skills author: borghei 7 files · 1 script body ≈ 1 777 tokens Open the sourcegithub.com↗ analyzed 7 h ago

Medical device risk management specialist implementing ISO 14971 throughout product lifecycle.

As a process C 50/100 · Has gaps — References files that are not bundled: ../quality-manager-qms-iso13485/, ../capa-officer/, ../regulatory-affairs-head/

AnalyzerManufacturingInfrastructuretype and topics are labelled automatically from the skill text
Runs in: Claude / Claude Code ChatGPT / Codex Gemini CLI Cursor GitHub Copilot / VS Code Qwen Code Kimi Code CLI Z.ai (GLM) DeepSeek (Deep Code) Mistral Vibe LangChain (deepagents) OpenClaw Goose OpenCode
JSON
Technical rating
C
88/100
safety, quality, tests
Safety 60%
94
Quality 40%
80
Run on models
none yet
Process rating
C
50/100
Has gaps
References files that are not bundled: ../quality-manager-qms-iso13485/, ../capa-officer/, ../regulatory-affairs-head/
Tools and files w 18
0
Inputs and preconditions w 11
0
Progress reporting w 2
0
the three weakest of ten parameters · all ten

How to improve

  1. The text references files that are not there: add them or drop the references.
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 · 6

✓ No critical or high findings

Medium and low: 6
  • low Risky intent intent-offensive-security references/extended-risk-domains.md:91
    Offensive-security / dual-use content (legitimate for authorised testing; review intended use)
    | Unauthorized access | Credential theft, privilege escalation | Modification of device settings → patient harm |
  • low Risky intent intent-offensive-security references/extended-risk-domains.md:92
    Offensive-security / dual-use content (legitimate for authorised testing; review intended use)
    | Data breach | PHI exfiltration, ransomware | Loss of data availability → delayed treatment |
  • low Risky intent intent-offensive-security references/extended-risk-domains.md:94
    Offensive-security / dual-use content (legitimate for authorised testing; review intended use)
    | Malware | Ransomware, trojans, supply chain compromise | Device malfunction → incorrect output |
  • low Risky intent intent-offensive-security references/extended-risk-domains.md:218
    Offensive-security / dual-use content (legitimate for authorised testing; review intended use)
    | Digital operational resilience testing (Art. 24-27) | Complement risk control verification | Include penetration testing in verification activities |
  • low Risky intent intent-offensive-security references/extended-risk-domains.md:288
    Offensive-security / dual-use content (legitimate for authorised testing; review intended use)
    - **Cybersecurity FMEA:** Failure modes include unauthorized access, data breach, ransomware, supply chain attack
  • low Risky intent intent-offensive-security SKILL.md:88
    Offensive-security / dual-use content (legitimate for authorised testing; review intended use)
    - Cybersecurity penetration testing or vulnerability scanning (use infrastructure-compliance-auditor for technical security testing)

Files scanned: 7. Evidence is masked. Grey chips explain why severity was lowered.

Against the Agent Skills spec

  • warning missing-ref reference to a missing file: ../quality-manager-qms-iso13485/
  • warning missing-ref reference to a missing file: ../capa-officer/
  • warning missing-ref reference to a missing file: ../regulatory-affairs-head/
  • warning missing-ref reference to a missing file: ../quality-documentation-manager/
  • warning missing-ref reference to a missing file: ../fda-consultant-specialist/
  • warning missing-ref reference to a missing file: ../infrastructure-compliance-auditor/
  • warning missing-ref reference to a missing file: ../nist-csf-specialist/

Process rating: all ten parameters 50/100

Will not run. References files that are not bundled: ../quality-manager-qms-iso13485/, ../capa-officer/, ../regulatory-affairs-head/
  • 0Tools and files. 7 referenced file(s) missing: ../quality-manager-qms-iso13485/, ../capa-officer/, ../regulatory-affairs-head/
  • 0Inputs and preconditions. Does not say what the process needs to start
  • 0Progress reporting. Says nothing while it works
  • 40Result and completion. Does not say what the result is
  • 50When it triggers. No condition that starts the skill
  • 55Failures and branches. 1 branches
  • 100Steps. 34 steps
  • 100Consistency. Name and required fields are in place
  • 100Execution cost. Instruction body is 1777 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
  • +2Single-language instructions
  • +3Description length 191: enough signal without eating the budget
  • +4Structure: 8 headings
  • +3Step-by-step instructions: 34 items
  • +4Has examples (1 code blocks)
  • +4Reference files are cited in the instructions (5 of 5)
  • +3All 1 scripts are documented
  • +1License stated

Quality base 70; lint remarks subtract, signals add up to 100. Result: 80.