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ra-qm-skills

12 regulatory & QM agent skills and plugins for Claude Code, Codex, Gemini CLI, Cursor, OpenClaw. ISO 13485 QMS, MDR 2017/745, FDA 510(k)/PMA, ISO 27001 ISMS, GDPR/DSGVO, risk management (ISO 14971), CAPA, document control, auditing. Python tools (stdlib-only).

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micsapp/micstec-skills

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查看安装方法

包含的文件（74）

  • SKILL.md2.2 KB
  • .claude-plugin/plugin.json640 B
  • .codex/instructions.md1.3 KB
  • capa-officer/references/effectiveness-verification-guide.md13.3 KB
  • capa-officer/references/rca-methodologies.md15.4 KB
  • capa-officer/scripts/capa_tracker.py20.5 KB
  • capa-officer/scripts/root_cause_analyzer.py17.4 KB
  • capa-officer/SKILL.md14.5 KB
  • CLAUDE.md4.3 KB
  • fda-consultant-specialist/references/device_cybersecurity_guidance.md17.9 KB
  • fda-consultant-specialist/references/fda_capa_requirements.md21.9 KB
  • fda-consultant-specialist/references/fda_submission_guide.md11.5 KB
  • fda-consultant-specialist/references/hipaa_compliance_framework.md18.8 KB
  • fda-consultant-specialist/references/qsr_compliance_requirements.md18.4 KB
  • fda-consultant-specialist/scripts/fda_submission_tracker.py19.2 KB
  • fda-consultant-specialist/scripts/hipaa_risk_assessment.py22.6 KB
  • fda-consultant-specialist/scripts/qsr_compliance_checker.py24.1 KB
  • fda-consultant-specialist/SKILL.md10.0 KB
  • final-complete-skills-collection.md8.6 KB
  • gdpr-dsgvo-expert/references/dpia_methodology.md10.7 KB
  • gdpr-dsgvo-expert/references/gdpr_compliance_guide.md8.8 KB
  • gdpr-dsgvo-expert/references/german_bdsg_requirements.md8.7 KB
  • gdpr-dsgvo-expert/scripts/data_subject_rights_tracker.py18.8 KB
  • gdpr-dsgvo-expert/scripts/dpia_generator.py20.2 KB
  • gdpr-dsgvo-expert/scripts/gdpr_compliance_checker.py15.1 KB
  • gdpr-dsgvo-expert/SKILL.md7.7 KB
  • information-security-manager-iso27001/references/incident-response.md11.0 KB
  • information-security-manager-iso27001/references/iso27001-controls.md9.4 KB
  • information-security-manager-iso27001/references/risk-assessment-guide.md8.2 KB
  • information-security-manager-iso27001/scripts/compliance_checker.py15.8 KB
  • information-security-manager-iso27001/scripts/risk_assessment.py16.9 KB
  • information-security-manager-iso27001/SKILL.md11.4 KB
  • isms-audit-expert/references/cloud-security-audit.md6.1 KB
  • isms-audit-expert/references/iso27001-audit-methodology.md6.6 KB
  • isms-audit-expert/references/security-control-testing.md7.0 KB
  • isms-audit-expert/scripts/isms_audit_scheduler.py8.9 KB
  • isms-audit-expert/SKILL.md7.5 KB
  • mdr-745-specialist/references/clinical-evidence-requirements.md9.2 KB
  • mdr-745-specialist/references/mdr-classification-guide.md8.7 KB
  • mdr-745-specialist/references/technical-documentation-templates.md10.1 KB
  • mdr-745-specialist/scripts/mdr_gap_analyzer.py17.7 KB
  • mdr-745-specialist/SKILL.md9.7 KB
  • qms-audit-expert/references/iso13485-audit-guide.md10.7 KB
  • qms-audit-expert/references/nonconformity-classification.md6.7 KB
  • qms-audit-expert/scripts/audit_schedule_optimizer.py13.4 KB
  • qms-audit-expert/SKILL.md9.5 KB
  • quality-documentation-manager/references/21cfr11-compliance-guide.md13.1 KB
  • quality-documentation-manager/references/document-control-procedures.md11.7 KB
  • quality-documentation-manager/scripts/document_validator.py22.3 KB
  • quality-documentation-manager/scripts/document_version_control.py16.6 KB
  • quality-documentation-manager/SKILL.md13.7 KB
  • quality-manager-qmr/references/management-review-guide.md10.1 KB
  • quality-manager-qmr/references/quality-kpi-framework.md11.5 KB
  • quality-manager-qmr/scripts/management_review_tracker.py19.0 KB
  • quality-manager-qmr/scripts/quality_effectiveness_monitor.py18.8 KB
  • quality-manager-qmr/SKILL.md17.6 KB
  • quality-manager-qms-iso13485/references/iso13485-clause-requirements.md22.4 KB
  • quality-manager-qms-iso13485/references/qms-process-templates.md19.5 KB
  • quality-manager-qms-iso13485/scripts/qms_audit_checklist.py29.5 KB
  • quality-manager-qms-iso13485/SKILL.md16.0 KB
  • README.md32.3 KB
  • regulatory-affairs-head/references/eu-mdr-submission-guide.md3.2 KB
  • regulatory-affairs-head/references/fda-submission-guide.md3.8 KB
  • regulatory-affairs-head/references/global-regulatory-pathways.md9.6 KB
  • regulatory-affairs-head/references/iso-regulatory-requirements.md13.8 KB
  • regulatory-affairs-head/scripts/regulatory_pathway_analyzer.py22.5 KB
  • regulatory-affairs-head/scripts/regulatory_tracker.py8.0 KB
  • regulatory-affairs-head/SKILL.md19.7 KB
  • risk-management-specialist/references/iso14971-implementation-guide.md14.1 KB
  • risk-management-specialist/references/risk-analysis-methods.md13.0 KB
  • risk-management-specialist/references/risk-assessment-templates.md1.9 KB
  • risk-management-specialist/scripts/fmea_analyzer.py15.9 KB
  • risk-management-specialist/scripts/risk_matrix_calculator.py13.9 KB
  • risk-management-specialist/SKILL.md15.1 KB

SKILL.md（原文）

安装前可以查看交给 AI 代理的指令内容。

Regulatory Affairs & Quality Management Skills

12 production-ready compliance skills for HealthTech and MedTech organizations.

Quick Start

Claude Code

/read ra-qm-team/regulatory-affairs-head/SKILL.md

Codex CLI

npx agent-skills-cli add alirezarezvani/claude-skills/ra-qm-team

Skills Overview

SkillFolderFocus
Regulatory Affairs Headregulatory-affairs-head/FDA/MDR strategy, submissions
Quality Manager (QMR)quality-manager-qmr/QMS governance, management review
Quality Manager (ISO 13485)quality-manager-qms-iso13485/QMS implementation, doc control
Risk Management Specialistrisk-management-specialist/ISO 14971, FMEA, risk files
CAPA Officercapa-officer/Root cause analysis, corrective actions
Quality Documentation Managerquality-documentation-manager/Document control, 21 CFR Part 11
QMS Audit Expertqms-audit-expert/ISO 13485 internal audits
ISMS Audit Expertisms-audit-expert/ISO 27001 security audits
Information Security Managerinformation-security-manager-iso27001/ISMS implementation
MDR 745 Specialistmdr-745-specialist/EU MDR classification, CE marking
FDA Consultantfda-consultant-specialist/510(k), PMA, QSR compliance
GDPR/DSGVO Expertgdpr-dsgvo-expert/Privacy compliance, DPIA

Python Tools

17 scripts, all stdlib-only:

python3 risk-management-specialist/scripts/risk_matrix_calculator.py --help
python3 gdpr-dsgvo-expert/scripts/gdpr_compliance_checker.py --help

Rules

  • Load only the specific skill SKILL.md you need
  • Always verify compliance outputs against current regulations

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