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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).

micsapp/micstec-skills
インストール方法を見る

含まれるファイル（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）

インストールする前に、エージェントに与えられる指示の中身を確認できます。

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

レビュー

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同じリポジトリのスキル

概要と使いどころ

acquiring-disk-image-with-dd-and-dcfldd

無料

Create forensically sound bit-for-bit disk images using dd and dcfldd while preserving evidence integrity through hash verification.

日本語の概要は準備中です。原文の説明を表示しています。

micsapp/micstec-skills42026年3月20日 更新

algorithmic-art

無料

Creating algorithmic art using p5.js with seeded randomness and interactive parameter exploration. Use this when users request creating art using code, generative art, algorithmic art, flow fields, or particle systems. Create original algorithmic art rather than copying existing artists' work to avoid copyright violations.

日本語の概要は準備中です。原文の説明を表示しています。

micsapp/micstec-skills42026年3月20日 更新

analyzing-active-directory-acl-abuse

無料

Detect dangerous ACL misconfigurations in Active Directory using ldap3 to identify GenericAll, WriteDACL, and WriteOwner abuse paths

日本語の概要は準備中です。原文の説明を表示しています。

micsapp/micstec-skills42026年3月20日 更新

analyzing-android-malware-with-apktool

無料

Perform static analysis of Android APK malware samples using apktool for decompilation, jadx for Java source recovery, and androguard for permission analysis, manifest inspection, and suspicious API call detection.

日本語の概要は準備中です。原文の説明を表示しています。

micsapp/micstec-skills42026年3月20日 更新

analyzing-api-gateway-access-logs

無料

Parses API Gateway access logs (AWS API Gateway, Kong, Nginx) to detect BOLA/IDOR attacks, rate limit bypass, credential scanning, and injection attempts. Uses pandas for statistical analysis of request patterns and anomaly detection. Use when investigating API abuse or building API-specific threat detection rules.

日本語の概要は準備中です。原文の説明を表示しています。

micsapp/micstec-skills42026年3月20日 更新

analyzing-apt-group-with-mitre-navigator

無料

Analyze advanced persistent threat (APT) group techniques using MITRE ATT&CK Navigator to create layered heatmaps of adversary TTPs for detection gap analysis and threat-informed defense.

日本語の概要は準備中です。原文の説明を表示しています。

micsapp/micstec-skills42026年3月20日 更新

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