Ra Qm Skills
Deploy twelve regulatory and quality-management agent skills for MedTech/HealthTech—ISO 13485, MDR, FDA 510(k)/PMA, ISO 27001, GDPR, CAPA, audits, and document control—with stdlib Python tooling.
Overview
ra-qm-skills is an agent skill most often used in Ship (also Validate scope and Operate iterate) that packages 12 MedTech regulatory and QMS agent skills for ISO 13485, MDR, FDA, ISO 27001, GDPR, risk, CAPA, and audits.
Install
npx skills add https://github.com/alirezarezvani/claude-skills --skill ra-qm-skillsWhat is this skill?
- 12 production-oriented RA/QM skills spanning regulatory head, QMR, ISO 13485 QMS, risk (ISO 14971), CAPA, doc control, a
- Coverage includes MDR 2017/745, FDA 510(k)/PMA pathways, ISO 27001 ISMS, and GDPR/DSGVO privacy obligations
- Python helper tools described as stdlib-only for offline-friendly compliance workflows
- Packaged for Claude Code, Codex CLI, Gemini-style CLIs, Cursor, and OpenClaw via documented install paths
- Role-based SKILL.md entry points (e.g. regulatory-affairs-head) for deep dives without loading the entire bundle at once
- 12 regulatory and QM agent skills in the bundle
- Python tools described as stdlib-only
- Covers ISO 13485, MDR 2017/745, FDA 510(k)/PMA, ISO 27001, and GDPR/DSGVO
Adoption & trust: 1.6k installs on skills.sh; 17.5k GitHub stars; 3/3 security scanners passed (skills.sh audits).
What problem does it solve?
You are shipping or maintaining a regulated health product but lack repeatable agent-guided workflows for QMS, submissions, risk files, CAPA, and audit evidence across FDA and EU frameworks.
Who is it for?
Indie HealthTech teams preparing ISO 13485-aligned QMS work, MDR/FDA submission support, or post-market CAPA and audit prep with agent assistance.
Skip if: Consumer apps with no medical or regulated health claims, or teams seeking generic OWASP appsec without QMS/regulatory context.
When should I use this skill?
Building or operating HealthTech/MedTech products needing ISO 13485 QMS, EU MDR, FDA submissions, risk management, CAPA, audits, or GDPR/ISMS agent guidance.
What do I get? / Deliverables
You load role-specific RA/QM skills and stdlib Python tools to produce structured compliance artifacts and audit-ready narratives aligned to named standards—still subject to qualified human review.
- Role-specific RA/QM agent outputs (risk files, CAPA records, audit checklists)
- Structured submission and QMS narrative drafts
- Traceable documentation aligned to cited standards
Recommended Skills
Journey fit
Spans multiple journey phases - primary shelf plus alternate fits below.
Ship/security is the canonical shelf because the bundle exists to evidence QMS, regulatory strategy, and risk controls before market release. Regulatory affairs, ISMS, and audit skills gate safe shipment of regulated software and devices; ongoing operate work is a natural follow-on, not the primary catalog entry point.
Where it fits
Classify device/software regulatory path (MDR vs FDA) before locking the MVP feature set.
Run QMS audit expert and ISO 27001 ISMS checks prior to release candidate sign-off.
Open a CAPA workflow and document control update after post-market feedback.
Draft controlled design documentation under quality-documentation-manager patterns.
How it compares
MedTech RA/QM skill bundle with ISO/FDA/MDR focus—not a general code review or DevOps deploy skill.
Common Questions / FAQ
Who is ra-qm-skills for?
Solo builders and small MedTech/HealthTech groups using Claude Code, Codex, Cursor, or OpenClaw who need structured RA and quality-management agent playbooks.
When should I use ra-qm-skills?
At Validate when scoping regulatory classification; during Build for controlled documentation; at Ship for security/compliance gates; in Operate for CAPA, audits, and management review cycles.
Is ra-qm-skills safe to install?
Skills may process sensitive quality and regulatory data in your environment—use least privilege and review the Security Audits panel on this Prism page before enterprise rollout.
SKILL.md
READMESKILL.md - Ra Qm Skills
# Regulatory Affairs & Quality Management Skills 12 production-ready compliance skills for HealthTech and MedTech organizations. ## Quick Start ### Claude Code ``` /read ra-qm-team/regulatory-affairs-head/SKILL.md ``` ### Codex CLI ```bash npx agent-skills-cli add alirezarezvani/claude-skills/ra-qm-team ``` ## Skills Overview | Skill | Folder | Focus | |-------|--------|-------| | Regulatory Affairs Head | `regulatory-affairs-head/` | FDA/MDR strategy, submissions | | Quality Manager (QMR) | `quality-manager-qmr/` | QMS governance, management review | | Quality Manager (ISO 13485) | `quality-manager-qms-iso13485/` | QMS implementation, doc control | | Risk Management Specialist | `risk-management-specialist/` | ISO 14971, FMEA, risk files | | CAPA Officer | `capa-officer/` | Root cause analysis, corrective actions | | Quality Documentation Manager | `quality-documentation-manager/` | Document control, 21 CFR Part 11 | | QMS Audit Expert | `qms-audit-expert/` | ISO 13485 internal audits | | ISMS Audit Expert | `isms-audit-expert/` | ISO 27001 security audits | | Information Security Manager | `information-security-manager-iso27001/` | ISMS implementation | | MDR 745 Specialist | `mdr-745-specialist/` | EU MDR classification, CE marking | | FDA Consultant | `fda-consultant-specialist/` | 510(k), PMA, QSR compliance | | GDPR/DSGVO Expert | `gdpr-dsgvo-expert/` | Privacy compliance, DPIA | ## Python Tools 17 scripts, all stdlib-only: ```bash python3 risk-management-specialist/scripts/risk_matrix_calculator.py --help python3 gdpr-dsgvo-expert/scripts/gdpr_compliance_checker.py --help ``` ## Rules - Load only the specific skill SKILL.md you need - Always verify compliance outputs against current regulations