ra-qm-skills

$npx mdskill add alirezarezvani/claude-skills/ra-qm-skills

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.

SKILL.md

.github/skills/ra-qm-skillsView on GitHub ↗
---
name: "ra-qm-skills"
description: "Router for regulatory and quality skills: ISO 13485, MDR, FDA, ISO 14971, CAPA, ISO 27001, ISO 42001, EU AI Act, GDPR, SOC 2. Use whenever a compliance request fits no single one."
license: MIT
metadata:
  version: 2.9.0
  author: Alireza Rezvani
  tags:
    - regulatory
    - quality-management
    - iso-13485
    - mdr
    - fda
    - iso-27001
    - gdpr
  agents:
    - 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

```bash
# 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).

More from alirezarezvani/claude-skills

SkillDescription
a11y-auditUse for any accessibility audit or a11y fix (WCAG 2.2 A/AA, color contrast, compliance report, CI check) in React, Next.js, Vue, Angular, Svelte or HTML. Scans with a11y_scanner.py and checks contrast with contrast_checker.py, then fixes and re-verifies.
ab-test-setupUse before planning or launching any A/B, split or multivariate test, or when asked if a result is significant. Sizes the test with sample_size_calculator.py and writes the hypothesis, metric and stop rule first, so it is not called early on noise.
access-lifecycleUse when preparing or running a user access review, checking that leavers lost their access, finding orphaned or ownerless service accounts, answering an auditor's access-control request for SOC 2, ISO 27001, PCI DSS, HIPAA or NIST 800-53, or checking whether a finished review campaign will hold up. Diffs the HR roster against account exports, tests the campaign for coverage, self-review, unremoved revokes and rubber-stamping, and maps every exception to the controls it breaks.
ad-creativeUse for any ad copy request (RSA headlines, Meta, LinkedIn or TikTok ads, bulk variations), before writing. Checks every line against platform character limits and policy with ad_copy_validator.py. Campaign strategy and budgets: paid-ads.
adversarial-reviewerTough, critical review of a diff or PR before merge, through hostile reviewer personas that catch shared blind spots. Use whenever the user wants a change torn apart, a harsh second opinion, or a self-review felt too agreeable.
aeoUse when content should be cited by ChatGPT, Perplexity, Claude or Gemini (answer engine optimization), before rewriting it. Scores E-E-A-T and structure with aeo_audit.py, rewrites with aeo_optimizer.py and logs citations with citation_tracker.py.
agent-decision-receiptsUse when an autonomous agent takes a side-effecting action (deploy, delete, pay, grant access) that may need proving later, or for EU AI Act Art. 12 record-keeping. Builds a tamper-evident signed receipt with build_action_manifest.py and verifies it.
agent-designerDesign multi-agent systems (supervisor, swarm, pipeline) and tool schemas; find bottlenecks in run logs. Use whenever agents split work or a run is slow or costly. Not for Claude Code workflow files (workflow-builder).
agent-harnessUse when an agent should drive a goal in one of this repo's domains to a verified close, before starting the work. Compiles the goal into a task plan with goal_compiler.py and runs it through loop_controller.py, which verifies each task, caps retries and escalates.
agent-launcher-orchestratorUse when someone wants to build, launch, grade or schedule a Claude Managed Agent in their own Anthropic account ('build me an agent', 'run this nightly'). Reads the session goal, routes with goal_router.py and compiles the loop with loop_compiler.py.