About

Imported from AshminDhungana/AI-Skillkit (miscellaneous-collection/ra-qm-team/skills/ra-qm-skills/SKILL.md). Install upstream with npx skills add AshminDhungana/AI-Skillkit --skill ra-qm-skills. Copyright stays with the author (MIT).

Regulatory Affairs & Quality Management Skills

Name: ra-qm-skills
Author: AshminDhungana

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 /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

Use it

Copy one of these into your project. Installing also returns the manifest and these snippets.

yaml

targets:
  - https://api.opensmartroute.ai/api/v1/registry/ashmindhungana-ai-skillkit-ra-qm-skills/manifest   # or paste the manifest below

Manifest

An Open Capability Manifest: the router reads it to know what this does, what it costs and when to pick it.

ashmindhungana-ai-skillkit-ra-qm-skills.ocm.jsonjson

{
  "ocm": "1",
  "id": "ashmindhungana-ai-skillkit-ra-qm-skills",
  "kind": "skill",
  "name": "ra-qm-skills",
  "description": "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).",
  "publisher": "AshminDhungana",
  "version": "1.0.0",
  "capabilities": {
    "domains": [
      "coding",
      "legal"
    ],
    "tags": [
      "skill-md",
      "regulatory",
      "quality-management",
      "iso-13485",
      "mdr",
      "fda",
      "iso-27001",
      "gdpr",
      "github"
    ],
    "languages": [
      "en"
    ]
  },
  "quality_prior": 0.6,
  "examples": [
    "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)."
  ],
  "primary": false,
  "metadata": {
    "source": {
      "provider": "github",
      "repository": "https://github.com/AshminDhungana/AI-Skillkit",
      "path": "miscellaneous-collection/ra-qm-team/skills/ra-qm-skills/SKILL.md",
      "ref": "6d0916e429f2a00b671fbd4f5ec824dafdd9c581",
      "url": "https://github.com/AshminDhungana/AI-Skillkit/blob/6d0916e429f2a00b671fbd4f5ec824dafdd9c581/miscellaneous-collection/ra-qm-team/skills/ra-qm-skills/SKILL.md",
      "key": "AshminDhungana/AI-Skillkit/miscellaneous-collection/ra-qm-team/skills/ra-qm-skills/SKILL.md"
    },
    "license": "MIT"
  },
  "instructions": "# Regulatory Affairs & Quality Management Skills\n\n12 production-ready compliance skills for HealthTech and MedTech organizations.\n\n## Quick Start\n\n### Claude Code\n```\n/read ra-qm-team/regulatory-affairs-head/SKILL.md\n```\n\n### Codex CLI\n```bash\nnpx agent-skills-cli add /claude-skills/ra-qm-team\n```\n\n## Skills Overview\n\n| Skill | Folder | Focus |\n|-------|--------|-------|\n| Regulatory Affairs Head | `regulatory-affairs-head/` | FDA/MDR strategy, submissions |\n| Quality Manager (QMR) | `quality-manager-qmr/` | QMS governance, management review |\n| Quality Manager (ISO 13485) | `quality-manager-q",
  "cost": {
    "context_tokens": 431
  }
}

Fetch it by URL: GET /api/v1/registry/ashmindhungana-ai-skillkit-ra-qm-skills/manifest?version=1.0.0

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