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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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Skills17
qms-audit-expert
/qms-audit-expert
ISO 13485 internal audit expertise for medical device QMS. Covers audit planning, execution, nonconformity classification, and CAPA verification. Use when planning internal audits, executing audits, classifying findings, preparing for external audits, or managing an audit program.
agent-decision-receipts
/agent-decision-receipts
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.
capa-officer
/capa-officer
CAPA system management for medical device QMS. Covers root cause analysis, corrective action planning, effectiveness verification, and CAPA metrics. Use when running 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, QMSR (21 CFR 820, which incorporates ISO 13485:2016 by reference since 2026-02-02; formerly QSR) compliance, HIPAA assessments, and device cybersecurity. Use when user mentions FDA submission, 510(k), PMA, De Novo, QMSR, QSR, ISO 13485 for FDA, premarket, predicate device, substantial equivalence, HIPAA medical device, or FDA cybersecurity.
The plugin manifest points to a different repository than the source indexed by ClaudePluginHub.
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Version2.9.0
LanguagePython
Stars1
MaintenanceExcellent
LicenseMIT
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