MCP.directory

ra-qm-skills

by alirezarezvani
3
1
Source

12 production-ready regulatory affairs and quality management skills for HealthTech/MedTech: ISO 13485 QMS, MDR 2017/745, FDA 510(k)/PMA, ISO 27001 ISMS, GDPR/DSGVO compliance, risk management (ISO 14971), CAPA, document control, and internal auditing. Python tools included (all stdlib-only). Works with Claude Code, Codex CLI, and OpenClaw.

Install

mkdir -p .claude/skills/ra-qm-skills && curl -L -o skill.zip "https://mcp.directory/api/skills/download/3456" && unzip -o skill.zip -d .claude/skills/ra-qm-skills && rm skill.zip

Installs to .claude/skills/ra-qm-skills

About this skill

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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