How do I install the Ra Qm Skills skill?

Run npx skillmds@latest add mhassan0000/ra-qm-skills-2 in your terminal (requires Node.js), paste this page's agent-chat prompt into Claude, Cursor, or any MCP-connected agent, or download the SKILL.md file and copy it into your agent's skills directory.

Is Ra Qm Skills safe to use?

This skill has not completed SkillMD's automated safety review yet. Independent scanners report: SkillSpector: PASS, Skill Scanner: PASS. SkillMD never runs a skill's scripts for you; review the SKILL.md before installing.

Which AI agents work with Ra Qm Skills?

This skill is tagged as working with Claude Code, Claude.ai, OpenAI Codex. SKILL.md is an open format, so most agents that read a skills directory can load it too.

Is Ra Qm Skills free to use?

Yes. Installing skills from SkillMD is free. This skill is licensed under MIT.

Who published Ra Qm Skills?

MHassan0000 (@mhassan0000) published this skill. Their other Agent Skills are listed on their SkillMD profile.

Ra Qm Skills by mhassan0000 — Agent Skill

Name: Ra Qm Skills
Author: MHassan0000

Ra Qm Skills

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').

MHassan0000 Updated Sep 21, 2026 1 repo stars

File contents

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).

---name: ra-qm-skills-2description: 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').license: MIT---# Regulatory Affairs & Quality Management Skills — RouterThis 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 tableMatch 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```bash# Example: route a risk-analysis requestcat ra-qm-team/skills/risk-management-specialist/SKILL.mdpython3 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).

Frequently asked questions