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ra-qm-skills
14 regulatory affairs & quality management skills for HealthTech/MedTech: ISO 13485 QMS, MDR 2017/745, FDA 510(k)/PMA, GDPR/DSGVO, ISO 27001 ISMS, SOC 2, CAPA management, risk management, clinical evaluation, and more. Agent skill and plugin for Claude Code, Codex, Gemini CLI, Cursor, OpenClaw.
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npx claudepluginhub marco3939/claude_skill --plugin ra-qm-skillsPopularity
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Med: 0·Avg: 271
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Med: 0·Avg: 2
What's Inside
Skills16
capa-officer
/capa-officer
CAPA system management for medical device QMS. Covers root cause analysis, corrective action planning, effectiveness verification, and CAPA metrics. Use for CAPA investigations, 5-Why analysis, fishbone diagrams, root cause determination, corrective action tracking, effectiveness verification, or CAPA program optimization.
eu-ai-act-specialist
/eu-ai-act-specialist
EU AI Act (Regulation (EU) 2024/1689) operational compliance for compliance teams. Three Article-level decisions: (1) What's the risk tier of this AI system — prohibited (Art. 5), high-risk (Art. 6 + Annex III), limited-risk (Art. 50), or minimal-risk? (2) For high-risk systems, what's the Article 43 conformity assessment route (Module A internal control vs Module H full QMS + notified body) and what goes in the Annex IV technical documentation? (3) Per organizational role (provider / deployer / importer / distributor / authorized representative), what are the active obligations and deadlines? Use during AI system intake review, when planning conformity assessment, or when scoping deployer obligations. Cites Articles + Annexes for every output. NOT executive AI strategy (see chief-ai-officer-advisor). NOT a legal substitute.
fda-consultant-specialist
/fda-consultant-specialist
FDA regulatory consultant for medical device companies. Provides 510(k)/PMA/De Novo pathway guidance, QSR (21 CFR 820) compliance, HIPAA assessments, and device cybersecurity. Use when user mentions FDA submission, 510(k), PMA, De Novo, QSR, premarket, predicate device, substantial equivalence, HIPAA medical device, or FDA cybersecurity.
gdpr-dsgvo-expert
/gdpr-dsgvo-expert
GDPR and German DSGVO compliance automation. Scans codebases for privacy risks, generates DPIA documentation, tracks data subject rights requests. Use for GDPR compliance assessments, privacy audits, data protection planning, DPIA generation, and data subject rights management.
quality-manager-qmr
/quality-manager-qmr
Senior Quality Manager Responsible Person (QMR) for HealthTech and MedTech companies. Provides quality system governance, management review leadership, regulatory compliance oversight, and quality performance monitoring per ISO 13485 Clause 5.5.2.
The plugin manifest points to a different repository than the source indexed by ClaudePluginHub.
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Version2.2.3
LanguagePython
Stars1
MaintenanceFair
LicenseMIT
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