Regulatory Affairs Router

Regulatory Affairs & Quality Management Skills — Router

by alirezarezvani · MIT license · ★ 26,349 on GitHub · v2.9.0 · updated Aug 30

Router/index for the 15 regulatory & quality-management skills bundled in this plugin (ISO 13485 QMS, EU MDR 2017/745, FDA submissions under QMSR, ISO 14971 risk, CAPA, document control, ISO 27001/ISMS, ISO 42001 AIMS, EU AI Act,…

---
name: "ra-qm-skills"
description: "Router/index for the 15 regulatory & quality-management skills bundled in this plugin (ISO 13485 QMS, EU MDR 2017/745, FDA submissions under QMSR, ISO 14971 risk, CAPA, document control, ISO 27001/ISMS, ISO 42001 AIMS, EU AI Act, GDPR/DSGVO, SOC 2, auditing). Use when a compliance request doesn't obviously match one skill and you need to pick the right one (e.g., 'prepare us for an ISO 13485 audit', 'is my AI system high-risk under the AI Act')."
version: 2.9.0
author: Alireza Rezvani
license: MIT
tags:
  - regulatory
  - quality-management
  - iso-13485
  - mdr
  - fda
  - iso-27001
  - gdpr
agents:
  - claude-code
  - codex-cli
  - openclaw

Overview

This plugin bundles 15 compliance skills for HealthTech/MedTech organizations (this router is the 16th folder under ra-qm-team/skills/). Each skill is self-contained.

Manual install (npx, ZIP)

Claude Codenpx skills add alirezarezvani/claude-skills --skill ra-qm-skills -g -a claude-code

Claude Code (manual)

mkdir -p ~/.claude/skills && curl -sL https://codeload.github.com/alirezarezvani/claude-skills/tar.gz/19392f7a0826 \
  | tar -xz -C ~/.claude/skills --strip-components=3 claude-skills-19392f7a0826/ra-qm-team/skills/ra-qm-skills

Windows (PowerShell)

New-Item -ItemType Directory -Force "$HOME\.claude\skills" | Out-Null; Invoke-WebRequest "https://m.agentalley.io/zip/7141d426ff647e7e19ab/ra-qm-skills.zip" -OutFile "$env:TEMP\ra-qm-skills.zip"; Expand-Archive "$env:TEMP\ra-qm-skills.zip" -DestinationPath "$HOME\.claude\skills" -Force

Claude.ai / desktopDownload the ZIP and upload it under Settings → Capabilities → Skills.

Codex, Cursor, other agentsPoint them at SKILL.md. The other files are plain text.

Connects with Agent Alley MCP · agentalley.io/mcp

Files included

SKILL.md3.3 KB

Read the files here

alirezarezvani/19392f71 file

SKILL.md3.3 KB

Shared references2SKILL.md reads these from elsewhere in the repo. Not in the ZIP.

Get them on GitHub ↗

SKILL.md

Show the full text60 lines

ra-qm-skills/SKILL.md60 lines · 3.3 KB

PreviewCode

Outline

RawView on GitHub

Regulatory Affairs & Quality Management Skills — Router

This plugin bundles 15 compliance skills for HealthTech/MedTech organizations (this router is the 16th folder under ra-qm-team/skills/). Each skill is self-contained.

Routing table

Match the request, then load ra-qm-team/skills/<skill>/SKILL.md. If multiple rows match, ask one clarifying question first.

Request signals	Skill	Path
Regulatory strategy, pathway selection, submissions planning	regulatory-affairs-head	`skills/regulatory-affairs-head/`
Management review, quality KPIs, QMR governance	quality-manager-qmr	`skills/quality-manager-qmr/`
ISO 13485 QMS implementation, process control	quality-manager-qms-iso13485	`skills/quality-manager-qms-iso13485/`
ISO 14971 risk analysis, FMEA, risk files	risk-management-specialist	`skills/risk-management-specialist/`
Root cause analysis, corrective/preventive actions	capa-officer	`skills/capa-officer/`
Document control, 21 CFR Part 11, DHF/DMR/DHR	quality-documentation-manager	`skills/quality-documentation-manager/`
ISO 13485 internal audits, NC classification	qms-audit-expert	`skills/qms-audit-expert/`
ISO 27001 audit planning and execution	isms-audit-expert	`skills/isms-audit-expert/`
ISMS design, security risk assessment	information-security-manager-iso27001	`skills/information-security-manager-iso27001/`
EU MDR classification, technical files, PSUR	mdr-745-specialist	`skills/mdr-745-specialist/`
FDA 510(k)/PMA/De Novo, QMSR	fda-consultant-specialist	`skills/fda-consultant-specialist/`
GDPR/DSGVO, DPIA, data subject rights	gdpr-dsgvo-expert	`skills/gdpr-dsgvo-expert/`
EU AI Act risk classification, obligations	eu-ai-act-specialist	`skills/eu-ai-act-specialist/`
ISO/IEC 42001 AI management system	iso42001-specialist	`skills/iso42001-specialist/`
SOC 2 Type I/II readiness, trust criteria	soc2-compliance	`skills/soc2-compliance/`

Quick start

# Example: route a risk-analysis request
cat ra-qm-team/skills/risk-management-specialist/SKILL.md
python3 ra-qm-team/skills/risk-management-specialist/scripts/risk_matrix_calculator.py --help

Rules

Route to exactly one skill, then follow that skill's workflow. This router ships no tools of its own.
All outputs are decision support: final compliance determinations route to the named human owner (QMR, DPO, regulatory counsel) — never auto-decide.
Verify regulatory citations against the current text (e.g., FDA QMSR effective 2026-02-02 replaced the legacy QSR subsections).

1	---
2	name: "ra-qm-skills"
3	description: "Router/index for the 15 regulatory & quality-management skills bundled in this plugin (ISO 13485 QMS, EU MDR 2017/745, FDA submissions under QMSR, ISO 14971 risk, CAPA, document control, ISO 27001/ISMS, ISO 42001 AIMS, EU AI Act, GDPR/DSGVO, SOC 2, auditing). Use when a compliance request doesn't obviously match one skill and you need to pick the right one (e.g., 'prepare us for an ISO 13485 audit', 'is my AI system high-risk under the AI Act')."
4	version: 2.9.0
5	author: Alireza Rezvani
6	license: MIT
7	tags:
8	- regulatory
9	- quality-management
10	- iso-13485
11	- mdr
12	- fda
13	- iso-27001
14	- gdpr
15	agents:
16	- claude-code
17	- codex-cli
18	- openclaw
19	---
20
21	# Regulatory Affairs & Quality Management Skills — Router
22
23	This plugin bundles 15 compliance skills for HealthTech/MedTech organizations (this router is the 16th folder under `ra-qm-team/skills/`). Each skill is self-contained.
24
25	## Routing table
26
27	Match the request, then load `ra-qm-team/skills/<skill>/SKILL.md`. If multiple rows match, ask one clarifying question first.
28
29	\| Request signals \| Skill \| Path \|
30	\|---\|---\|---\|
31	\| Regulatory strategy, pathway selection, submissions planning \| regulatory-affairs-head \| `skills/regulatory-affairs-head/` \|
32	\| Management review, quality KPIs, QMR governance \| quality-manager-qmr \| `skills/quality-manager-qmr/` \|
33	\| ISO 13485 QMS implementation, process control \| quality-manager-qms-iso13485 \| `skills/quality-manager-qms-iso13485/` \|
34	\| ISO 14971 risk analysis, FMEA, risk files \| risk-management-specialist \| `skills/risk-management-specialist/` \|
35	\| Root cause analysis, corrective/preventive actions \| capa-officer \| `skills/capa-officer/` \|
36	\| Document control, 21 CFR Part 11, DHF/DMR/DHR \| quality-documentation-manager \| `skills/quality-documentation-manager/` \|
37	\| ISO 13485 internal audits, NC classification \| qms-audit-expert \| `skills/qms-audit-expert/` \|
38	\| ISO 27001 audit planning and execution \| isms-audit-expert \| `skills/isms-audit-expert/` \|
39	\| ISMS design, security risk assessment \| information-security-manager-iso27001 \| `skills/information-security-manager-iso27001/` \|
40	\| EU MDR classification, technical files, PSUR \| mdr-745-specialist \| `skills/mdr-745-specialist/` \|
41	\| FDA 510(k)/PMA/De Novo, QMSR \| fda-consultant-specialist \| `skills/fda-consultant-specialist/` \|
42	\| GDPR/DSGVO, DPIA, data subject rights \| gdpr-dsgvo-expert \| `skills/gdpr-dsgvo-expert/` \|
43	\| EU AI Act risk classification, obligations \| eu-ai-act-specialist \| `skills/eu-ai-act-specialist/` \|
44	\| ISO/IEC 42001 AI management system \| iso42001-specialist \| `skills/iso42001-specialist/` \|
45	\| SOC 2 Type I/II readiness, trust criteria \| soc2-compliance \| `skills/soc2-compliance/` \|
46
47	## Quick start
48
49	```bash
50	# Example: route a risk-analysis request
51	cat ra-qm-team/skills/risk-management-specialist/SKILL.md
52	python3 ra-qm-team/skills/risk-management-specialist/scripts/risk_matrix_calculator.py --help
53	```
54
55	## Rules
56
57	- Route to exactly one skill, then follow that skill's workflow. This router ships no tools of its own.
58	- All outputs are decision support: final compliance determinations route to the named human owner (QMR, DPO, regulatory counsel) — never auto-decide.
59	- Verify regulatory citations against the current text (e.g., FDA QMSR effective 2026-02-02 replaced the legacy QSR subsections).
60