Agent skill · marketing growth · alirezarezvani

ra-qm-skills

Router for regulatory and quality skills: ISO 13485, MDR, FDA, ISO 14971, CAPA, ISO 27001, ISO 42001, EU AI Act, GDPR, SOC 2. Use whenever a compliance request fits no single one.

Why this skill is useful

Provides a structured routing mechanism for compliance requests, enabling the AI to navigate complex regulatory frameworks effectively.

What it needs

About 2k tokens when loaded. Last updated 2026-08-05. 23,939 stars on the source repository.

What this skill does

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 signals Skill Path --- --- --- Regulatory strategy, pathway selection, submissions planning regulatory-affairs-head skills/regulatory-affairs-head/ Management review, quality KPIs, QMR governance quality-manager-qmr skills/quality-manager-qmr/ ISO 13485 QMS implementation, process control quality-manager-qms-iso13485 skills/quality-manager-qms-iso13485/ ISO 14971 risk analysis, FMEA, risk files risk-management-specialist skills/risk-management-specialist/ Root cause analysis, corrective/preventive actions capa-officer skills/capa-officer/ Document control, 21 CFR Part 11, DHF/DMR/DHR quality-documentation-manager skills/quality-documentation-manager/ ISO 13485 internal audits, NC classification qms-audit-expert skills/qms-audit-expert/ ISO 27001 audit planning and execution isms-audit-expert skills/isms-audit-expert/ ISMS design, security risk assessment information-security-manager-iso27001 skills/information-security-manager-iso27001/ EU MDR classification, technical files, PSUR mdr-745-specialist skills/mdr-745-specialist/ FDA 510(k)/PMA/De Novo, QMSR fda-consultant-specialist skills/fda-consultant-specialist/ GDPR/DSGVO, DPIA, data subject rights gdpr-dsgvo-expert skills/gdpr-dsgvo-expert/ EU AI Act risk classification, obligations eu-ai-act-specialist skills/eu-ai-act-specialist/ ISO/IEC 42001 AI management system iso42001-specialist skills/iso42001-specialist/ SOC 2 Type I/II readiness, trust criteria soc2-compliance skills/soc2-compliance/ Quick start Rules Route to exactly one skill, then follow that skill's workflow. This router ships no tools of its own. …

How to use it

Reference it in AdaL, Claude Code, Cursor or any coding agent — nothing to install:

@skills alirezarezvani/ra-qm-skills--5cadb5

View the source on GitHub

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