zhangzhang-111-i/claude-skills111/ra-qm-team

Name: ra-qm-team
Author: zhangzhang-111-i

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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

npx vskill@latest install zhangzhang-111-i/claude-skills111/ra-qm-team

SKILL.md

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

Security

Security scanPassed, 95 of 100Pattern checks on the skill's files.
Model reviewPassed

See the full security report

Quality evaluation

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Source

SKILL.md in the repositoryCheckingra-qm-team/SKILL.md

Popularity

7-day trend score: 5

Not refreshed yet.

Works with

Any agent vskill installs to: 56 targets in all. These 39 have a page on this site.

Claude Code
Cursor
GitHub Copilot
Windsurf
Codex
Gemini CLI
Cline
Amp
Roo Code
Goose
Continue
Kilo Code
Junie
Trae
OpenHands
Qwen Code
AI Agent
Tabnine Chat
Sourcegraph Cody
Amazon Q
Firebase Genkit
Sweep
Devin
Phind
Mentat
Claude Desktop
Aider
GPT Pilot
Plandex
bolt.new
v0
Replit Agent
Anse
TypingMind
BetterChatGPT
LibreChat
Warp AI
Pieces
Fig AI

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