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ra-qm-skills

Router/index for the 15 regulatory & quality-management skills bundled in this plugin (ISO 13485 QMS, EU MDR 2017/745, FDA submissions under QMSR, ISO 14971 risk, CAPA, document control, ISO 27001/ISMS, ISO 42001 AIMS, EU AI Act, GDPR/DSGVO, SOC 2, auditing). Use when a compliance request doesn't obviously match one skill and you need to pick the right one (e.g., 'prepare us for an ISO 13485 audit', 'is my AI system high-risk under the AI Act').

インストール方法を見る

含まれるファイル(1)

  • SKILL.md3.3 KB

SKILL.md(原文)

インストールする前に、エージェントに与えられる指示の中身を確認できます。

Regulatory Affairs & Quality Management Skills — Router

This plugin bundles 15 compliance skills for HealthTech/MedTech organizations (this router is the 16th folder under ra-qm-team/skills/). Each skill is self-contained.

Routing table

Match the request, then load ra-qm-team/skills/<skill>/SKILL.md. If multiple rows match, ask one clarifying question first.

Request signalsSkillPath
Regulatory strategy, pathway selection, submissions planningregulatory-affairs-headskills/regulatory-affairs-head/
Management review, quality KPIs, QMR governancequality-manager-qmrskills/quality-manager-qmr/
ISO 13485 QMS implementation, process controlquality-manager-qms-iso13485skills/quality-manager-qms-iso13485/
ISO 14971 risk analysis, FMEA, risk filesrisk-management-specialistskills/risk-management-specialist/
Root cause analysis, corrective/preventive actionscapa-officerskills/capa-officer/
Document control, 21 CFR Part 11, DHF/DMR/DHRquality-documentation-managerskills/quality-documentation-manager/
ISO 13485 internal audits, NC classificationqms-audit-expertskills/qms-audit-expert/
ISO 27001 audit planning and executionisms-audit-expertskills/isms-audit-expert/
ISMS design, security risk assessmentinformation-security-manager-iso27001skills/information-security-manager-iso27001/
EU MDR classification, technical files, PSURmdr-745-specialistskills/mdr-745-specialist/
FDA 510(k)/PMA/De Novo, QMSRfda-consultant-specialistskills/fda-consultant-specialist/
GDPR/DSGVO, DPIA, data subject rightsgdpr-dsgvo-expertskills/gdpr-dsgvo-expert/
EU AI Act risk classification, obligationseu-ai-act-specialistskills/eu-ai-act-specialist/
ISO/IEC 42001 AI management systemiso42001-specialistskills/iso42001-specialist/
SOC 2 Type I/II readiness, trust criteriasoc2-complianceskills/soc2-compliance/

Quick start

# Example: route a risk-analysis request
cat ra-qm-team/skills/risk-management-specialist/SKILL.md
python3 ra-qm-team/skills/risk-management-specialist/scripts/risk_matrix_calculator.py --help

Rules

  • Route to exactly one skill, then follow that skill's workflow. This router ships no tools of its own.
  • All outputs are decision support: final compliance determinations route to the named human owner (QMR, DPO, regulatory counsel) — never auto-decide.
  • Verify regulatory citations against the current text (e.g., FDA QMSR effective 2026-02-02 replaced the legacy QSR subsections).

レビュー

まだレビューはありません。使ってみた感想をお寄せください。

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概要と使いどころ

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日本語の概要は準備中です。原文の説明を表示しています。

alirezarezvani/claude-skills2.8万2026年8月30日 更新

When the user wants to plan, design, or implement an A/B test or experiment. Also use when the user mentions "A/B test," "split test," "experiment," "test this change," "variant copy," "multivariate test," "hypothesis," "conversion experiment," "statistical significance," or "test this." For tracking implementation, see analytics-tracking.

日本語の概要は準備中です。原文の説明を表示しています。

alirezarezvani/claude-skills2.8万2026年8月30日 更新

When the user needs to generate, iterate, or scale ad creative for paid advertising. Use when they say 'write ad copy,' 'generate headlines,' 'create ad variations,' 'bulk creative,' 'iterate on ads,' 'ad copy validation,' 'RSA headlines,' 'Meta ad copy,' 'LinkedIn ad,' or 'creative testing.' This is pure creative production — distinct from paid-ads (campaign strategy). Use ad-creative when you need the copy, not the campaign plan.

日本語の概要は準備中です。原文の説明を表示しています。

alirezarezvani/claude-skills2.8万2026年8月30日 更新

Adversarial code review that breaks the self-review monoculture. Use when you want a genuinely critical review of recent changes, before merging a PR, or when you suspect Claude is being too agreeable about code quality. Forces perspective shifts through hostile reviewer personas that catch blind spots the author's mental model shares with the reviewer.

日本語の概要は準備中です。原文の説明を表示しています。

alirezarezvani/claude-skills2.8万2026年8月30日 更新

aeo

無料

Answer Engine Optimization (AEO) skill — optimize content to be cited by AI language models (ChatGPT, Perplexity, Claude, Gemini, Mistral) as authoritative sources. Distinct from SEO — AEO optimizes for citation in LLM-generated responses, not search rankings. Use when planning content for AI-first search audiences, auditing existing content for E-E-A-T signals, tracking which pages get cited by which LLMs, or building a citation-friendly content strategy. Triggers — 'AEO audit', 'optimize for ChatGPT', 'get cited by Perplexity', 'LLM citation strategy', 'answer engine optimization', 'content for AI search', 'E-E-A-T audit'. Output is a markdown audit report (default) or JSON for pipeline integration. Stdlib-only Python tools.

日本語の概要は準備中です。原文の説明を表示しています。

alirezarezvani/claude-skills2.8万2026年8月30日 更新

Mint a tamper-evident, post-quantum-signed receipt for a consequential agent action (deploy, delete, pay, grant-access, model decision) so it can be verified later from the certificate alone. Use when an autonomous agent takes a side-effecting action that may need to be proven later, or when satisfying EU AI Act Article 12 record-keeping. Three decisions: whether an action needs a receipt, minting it, verifying it. Signing is delegated to the open-source OpenAgentOntology package. Not after-the-fact log analysis; not a hosted notary; not a legal opinion.

日本語の概要は準備中です。原文の説明を表示しています。

alirezarezvani/claude-skills2.8万2026年8月30日 更新

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