Regulatory Affairs & Quality Management Skills — Router
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).
How to use it
Claude Code
- Run the line below. It pulls the whole folder into
~/.claude/skills/ra-qm-skills. - Describe your job in plain words. Claude Code follows the skill from there.
Claude Code — installs the whole folder, not just SKILL.md
npx degit alirezarezvani/claude-skills/ra-qm-team/skills/ra-qm-skills#main ~/.claude/skills/ra-qm-skillsFor one project only, change the path to .claude/skills/ra-qm-skills.
Claude (web or desktop app)
- On this page open ⋯ → Download .md.
- Save it as SKILL.md in a folder, zip the folder, then Customize → Skills → + → Create skill → Upload a skill.
- Pick the file and Save. Claude shows the name and description and runs a security scan.
- Check the skill is switched on.
- Start a new chat and describe your job in plain words. The AI follows the skill from there.
ChatGPT or another app
- ChatGPT: make a Project and paste it into Instructions.
- Neither? Paste it at the top of a new chat — it works for that chat.
Not working?
- Check which app you pasted it into — the steps above name the right one.
- Some skills need the paid tier of Claude or ChatGPT.
Paste into Claude, ChatGPT or Cursor.
Source of Regulatory Affairs & Quality Management Skills — Router
Show the full text60 lines
| name | description | version | author | license | tags | agents |
|---|---|---|---|---|---|---|
| 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'). | 2.9.0 | Alireza Rezvani | MIT | - regulatory - quality-management - iso-13485 - mdr - fda - iso-27001 - gdpr | - claude-code - codex-cli - openclaw |
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 | |
| 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 |
Discussion
Gdpr data handlingImplement GDPR-compliant data handling with consent management, data subject rights, and privacy by design. Use when building systems that process EU personal data, implementing privacy controls, or conducting GDPR compliance reviews.Pci complianceImplement PCI DSS compliance requirements for secure handling of payment card data and payment systems. Use when securing payment processing, achieving PCI compliance, or implementing payment card security measures./cs:ciso-review — CISO Forcing Questions/cs:ciso-review <plan> — Risk-paranoid interrogation of any plan that touches data, compliance, or production access. Use when launching features that handle customer data, before a SOC 2 / ISO audit, or after any incident or near-miss.Compliance OS — Meta-OrchestratorCompliance OS — meta-orchestrator that lets compliance teams CONFIGURE which frameworks apply, COMPUTE cross-framework control overlap, SIMULATE internal audits, and CONSOLIDATE evidence across multiple frameworks. Four decisions: (1) Given a company profile, which of the 12 supported frameworks apply (ISO 27001/13485/42001/14971, EU AI Act, MDR 745, GDPR, SOC 2, FDA QSR, NIST CSF 2.0, NIS2, HIPAA)? (2) Across selected frameworks, which controls overlap and how much evidence reuses? (3) For a given framework + scope, what does a realistic mock audit produce — drawing from the 205-scenario library? (4) Across selected frameworks, what's the unified evidence checklist with reuse map? Use when standing up a multi-framework program, planning the annual audit calendar, or preparing for certification stage 1. Does NOT replace per-framework skills (it orchestrates them).
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