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…

INSTALLATION
npx skills add https://github.com/alirezarezvani/claude-skills --skill ra-qm-skills
Run in your project or agent environment. Adjust flags if your CLI version differs.

SKILL.md

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).
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