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ra-qm-skills

Routes regulatory and quality management requests to one of 15 specialist skills. Helps HealthTech and MedTech teams select the right workflow for audits, medical device regulations, information security, privacy, or AI compliance.

한국어 요약은 준비 중입니다. 영어 요약을 표시하고 있습니다.

원문원문 설명 보기

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').

설치 방법 보기

이럴 때 유용합니다

  • Choosing a skill for ISO 13485 audit preparation
  • Routing questions about EU AI Act risk classification
  • Finding the right workflow for GDPR requests
  • Clarifying where a compliance request belongs

포함된 파일(1)

  • SKILL.md3.3 KB

SKILL.md(원문)

설치하기 전에 에이전트에게 전달되는 지시 내용을 확인할 수 있습니다.

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).

리뷰

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aeo

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