SKILL

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').

Published by @Alireza Rezvani·from alirezarezvani/claude-skills·0 agent reads / 30d·0 saves·

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).

Bundled with this artifact

2 files

Reference files that ship alongside this artifact. Agents pull these in only when the task needs them.

More on the bench

SKILL▲0

Iso42001 Specialist

ISO/IEC 42001:2023 AI Management System (AIMS) specialist for compliance teams running internal audits. Three decisions: (1) Where are the gaps against Clauses 4-10 and what do we close first? (2) What goes in the AI risk register and which Annex A controls treat each risk? (3) What's the 12-month internal audit plan that satisfies Clause 9.2? Use when preparing for certification, scoping internal audit cycles, or onboarding AI systems into an existing ISMS (27001) / QMS (13485) program. NOT an executive AI strategy skill (see chief-ai-officer-advisor). NOT EU AI Act compliance (see compliance-team-eu-ai-act).

Alireza Rezvani
compliance+2
⊙ 0
SKILL▲0

Isms Audit Expert

Information Security Management System (ISMS) audit expert for ISO 27001 compliance verification, security control assessment, and certification support. Use when the user mentions ISO 27001, ISMS audit, Annex A controls, Statement of Applicability (SOA), gap analysis, nonconformity management, internal audit, surveillance audit, or security certification preparation. Helps review control implementation evidence, document audit findings, classify nonconformities, generate risk-based audit plans, map controls to Annex A requirements, prepare Stage 1 and Stage 2 audit documentation, and support corrective action workflows.

Alireza Rezvani
compliance+2
⊙ 1
SKILL▲0

Compliance Check

Run a compliance check on a proposed action, product feature, or business initiative, surfacing applicable regulations, required approvals, and risk areas. Use when launching a feature that touches personal data, when marketing or product proposes something with regulatory implications, or when you need to know which approvals and jurisdictional requirements apply before proceeding.

Anthropic
legal+2
⊙ 1