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Regulatory & QualityFree Safe

ra-qm-skills

Security Scan Summary

Status: Safe

Source: Syntic Skills registry

Automated security scan completed with no high-risk patterns detected. Manual review is still required.

About This Skill

Use when a HealthTech/MedTech compliance request doesn't obviously match one domain and you need to route it to the right regulatory or quality-management specialty.

Downloadable SKILL.md

Download SKILL.md and place it in your Syntic skills folder. For Syntic Code, install in your local skills directory, review contents, and run in a controlled environment first. Acknowledge the risk notice above to enable the download.

SKILL.md

---
name: ra-qm-skills
description: Use when a HealthTech/MedTech compliance request doesn't obviously match one domain and you need to route it to the right regulatory or quality-management specialty.
category: Regulatory & Quality
version: 1.0.0
tools: []
---

# Regulatory Affairs & Quality Management — Domain Map

Index of the regulatory and quality-management specialties covered across this HealthTech/MedTech compliance skill set, so a request can be matched to the right domain approach.

## Domain Map

Match the request signal to the domain, then apply that domain's methodology. If multiple domains match, ask one clarifying question first.

| Request signals | Domain |
|---|---|
| Regulatory strategy, pathway selection, submissions planning | Regulatory affairs leadership |
| Management review, quality KPIs, QMR governance | Quality Manager Responsible Person (QMR) |
| ISO 13485 QMS implementation, process control | QMS / ISO 13485 |
| ISO 14971 risk analysis, FMEA, risk files | Risk management |
| Root cause analysis, corrective/preventive actions | CAPA |
| Document control, 21 CFR Part 11, DHF/DMR/DHR | Quality documentation |
| ISO 13485 internal audits, NC classification | QMS audit |
| ISO 27001 audit planning and execution | ISMS audit |
| ISMS design, security risk assessment | Information security management (ISO 27001) |
| EU MDR classification, technical files, PSUR | EU MDR 2017/745 |
| FDA 510(k)/PMA/De Novo, QMSR | FDA consulting |
| GDPR/DSGVO, DPIA, data subject rights | GDPR/DSGVO |
| EU AI Act risk classification, obligations | EU AI Act |
| ISO/IEC 42001 AI management system | ISO 42001 AIMS |
| SOC 2 Type I/II readiness, trust criteria | SOC 2 compliance |

If a request falls squarely in one of these narrower domains and a teammate with that specialization is available, @mention them rather than working outside your depth.

## Rules

- Apply exactly one domain's methodology per request; don't blend frameworks.
- 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) via web_search before relying on them.

Bundle Download

Includes SKILL.md and bundled support files where provided. Risk acknowledgement is required.

Install Targets

Syntic App

1. Create a dedicated folder for this skill in your local skills library.
2. Place SKILL.md into that folder.
3. Restart Syntic and invoke this skill on matching tasks.

Syntic Code (CLI)

1. Save SKILL.md in your local Syntic Code skills directory.
2. Keep related files in the same skill folder.
3. Run in a safe environment and validate outputs.

Source

https://github.com/alirezarezvani/claude-skills/blob/main/ra-qm-team/skills/ra-qm-skills/SKILL.md

Open Source Link

Regulatory & Quality

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