ra-qm-skills
A regulatory compliance collection for MedTech, covering ISO standards, FDA requirements, and quality system documentation.
Install
mkdir -p .claude/skills/ra-qm-skills && curl -L -o skill.zip "https://agentskills.codes/api/skills/download/3456" && unzip -o skill.zip -d .claude/skills/ra-qm-skills && rm skill.zipInstalls to .claude/skills/ra-qm-skills
Activation
This is the description your AI agent reads to decide when to run this skill — the better it matches your request, the more reliably it fires.
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').Key capabilities
- →Route compliance requests
- →Identify regulatory skills
- →Support ISO 13485 QMS
- →Manage FDA submission planning
- →Facilitate audit preparation
How it works
Acts as a router for 15 specialized regulatory and quality management skills, matching user requests to the appropriate skill folder based on defined signals.
Inputs & outputs
When to use ra-qm-skills
- →ISO 13485 compliance
- →FDA 510(k) documentation
- →Manage CAPA workflows
- →GDPR compliance checks
About this skill
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).
When not to use it
- →Directly making final compliance determinations
- →Executing compliance tasks without routing
Prerequisites
Limitations
- →Does not ship tools of its own
- →Requires human owner for final compliance determinations
How it compares
Provides a centralized routing mechanism for a suite of specialized compliance tools rather than attempting to handle all domains in one tool.
Compared to similar skills
ra-qm-skills side by side with the closest alternatives in the catalog.
| Skill | Installs | Updated | Safety | Difficulty |
|---|---|---|---|---|
| ra-qm-skills (this skill) | 1 | 2mo | Review | Advanced |
| fda-medtech-compliance-auditor | 0 | 3mo | No flags | Advanced |
| security-requirement-extraction | 7 | 2mo | No flags | Intermediate |
| gdpr-dsgvo-expert | 8 | 7mo | Review | Advanced |
Try saying
Example prompts that trigger this skill in your AI assistant.
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