---
id: daily-ra-qm-skills
name: "ra-qm-skills"
url: https://skills.yangsir.net/skill/daily-ra-qm-skills
author: alirezarezvani
domain: healthcare
tags: ["legal-compliance", "regulatory-compliance", "risk-management"]
install_count: 1700
rating: 4.30 (20 reviews)
github: https://github.com/alirezarezvani/claude-skills
---

# ra-qm-skills

> 为健康科技和医疗科技组织提供 12 个生产就绪的法规事务与质量管理技能，确保合规性和质量标准

**Stats**: 1,700 installs · 4.3/5 (20 reviews)

## Before / After 对比

### 手动合规管理 vs 自动化合规

**Before**:

手动研究 FDA、CE、ISO 等法规要求，编写合规文档，跟踪法规变更，管理审核流程，容易遗漏重要更新

**After**:

使用预配置的合规技能，自动生成符合标准的文档，跟踪法规变更，管理审核流程，确保持续合规

| Metric | Before | After | Change |
|---|---|---|---|
| 合规时间 | 40小时/月 | 8小时/月 | -80% |

## Readme

# ra-qm-skills

# 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

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:

```
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

Weekly Installs256Repository[alirezarezvani/…e-skills](https://github.com/alirezarezvani/claude-skills)GitHub Stars6.7KFirst SeenMar 9, 2026Security Audits[Gen Agent Trust HubPass](/alirezarezvani/claude-skills/ra-qm-skills/security/agent-trust-hub)[SocketWarn](/alirezarezvani/claude-skills/ra-qm-skills/security/socket)[SnykPass](/alirezarezvani/claude-skills/ra-qm-skills/security/snyk)Installed oncodex245opencode245gemini-cli244github-copilot243amp243kimi-cli243

---
*Source: https://skills.yangsir.net/skill/daily-ra-qm-skills*
*Markdown mirror: https://skills.yangsir.net/api/skill/daily-ra-qm-skills/markdown*