Claude Code · Community skill
Regulatory Affairs & Quality Management Skills
12 production-ready compliance skills for HealthTech and MedTech organizations.
What this skill covers
This page keeps a stable Remote OpenClaw URL for the upstream skillwhile preserving the original source content below. The shell stays consistent, and the body can vary as much as the upstream SKILL.md or README varies.
Source files and registry paths
Source path
ra-qm-team/skills/ra-qm-skills
Entry file
ra-qm-team/skills/ra-qm-skills/SKILL.md
Repository
alirezarezvani/claude-skills
Format
markdown-skill
Original source content
Raw file# 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 ```bash npx agent-skills-cli add alirezarezvani/claude-skills/ra-qm-team ``` ## Skills Overview | Skill | Folder | Focus | |-------|--------|-------| | Regulatory Affairs Head | `regulatory-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 Specialist | `risk-management-specialist/` | ISO 14971, FMEA, risk files | | CAPA Officer | `capa-officer/` | Root cause analysis, corrective actions | | Quality Documentation Manager | `quality-documentation-manager/` | Document control, 21 CFR Part 11 | | QMS Audit Expert | `qms-audit-expert/` | ISO 13485 internal audits | | ISMS Audit Expert | `isms-audit-expert/` | ISO 27001 security audits | | Information Security Manager | `information-security-manager-iso27001/` | ISMS implementation | | MDR 745 Specialist | `mdr-745-specialist/` | EU MDR classification, CE marking | | FDA Consultant | `fda-consultant-specialist/` | 510(k), PMA, QSR compliance | | GDPR/DSGVO Expert | `gdpr-dsgvo-expert/` | Privacy compliance, DPIA | ## Python Tools 17 scripts, all stdlib-only: ```bash 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
Related Claude Code skills
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CAPA Officer
Corrective and Preventive Action (CAPA) management within Quality Management Systems, focusing on systematic root cause analysis, action implementation, and effectiveness verification.
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FDA Consultant Specialist
FDA regulatory consulting for medical device manufacturers covering submission pathways, Quality System Regulation (QSR), HIPAA compliance, and device cybersecurity requirements.
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GDPR/DSGVO Expert
Tools and guidance for EU General Data Protection Regulation (GDPR) and German Bundesdatenschutzgesetz (BDSG) compliance.
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Head Of Regulatory Affairs
Regulatory strategy development, submission management, and global market access for medical device organizations.
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Information Security Manager ISO 27001
Implement and manage Information Security Management Systems (ISMS) aligned with ISO 27001:2022 and healthcare regulatory requirements.
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ISMS Audit Expert
Internal and external ISMS audit management for ISO 27001 compliance verification, security control assessment, and certification support.
