tools-only Regulatory Affairs & Quality Management Skills - Claude Code Guidance
This guide covers the 12 production-ready RA/QM compliance skills for HealthTech/MedTech companies.
RA/QM Skills Overview
Strategic Leadership (2 skills):
- regulatory-affairs-head - RA strategy, regulatory intelligence, authority relations
- quality-manager-qmr - QMS oversight, management review, quality culture
Quality Systems (3 skills):
- quality-manager-qms-iso13485 - ISO 13485 compliance, process management
- capa-officer - CAPA system management, root cause analysis
- quality-documentation-manager - DHF, DMR, DHR management
Risk & Security (2 skills):
- risk-management-specialist - ISO 14971 compliance, risk analysis
- information-security-manager-iso27001 - ISO 27001, data protection, ISMS
Regulatory Specialists (2 skills):
- mdr-745-specialist - EU MDR 2017/745 compliance, technical documentation
- fda-consultant-specialist - FDA 510(k), PMA, QSR compliance
Audit & Compliance (3 skills):
- qms-audit-expert - Internal audits, ISO 13485 certification
- isms-audit-expert - ISO 27001 audits, security assessments
- gdpr-dsgvo-expert - GDPR/DSGVO compliance, data privacy
Total: 12 specialized compliance skills for medical device industry
Compliance Frameworks
ISO 13485 (Medical Device Quality Management)
Managed by: quality-manager-qms-iso13485, qms-audit-expert
Key Areas:
- Management responsibility
- Resource management
- Product realization
- Measurement, analysis, improvement
Tools:
- QMS process mapping
- Document control systems
- Change management workflows
ISO 14971 (Medical Device Risk Management)
Managed by: risk-management-specialist
Key Areas:
- Risk analysis and evaluation
- Risk control measures
- Residual risk evaluation
- Risk management review
Tools:
- Risk assessment templates
- FMEA/FMECA analysis
- Risk-benefit analysis
MDR 2017/745 (EU Medical Device Regulation)
Managed by: mdr-745-specialist
Key Areas:
- Technical documentation (Annex II, III)
- Clinical evaluation (Annex XIV)
- Post-market surveillance
- UDI (Unique Device Identification)
FDA Regulations (US Medical Device Compliance)
Managed by: fda-consultant-specialist
Key Areas:
- 510(k) premarket notification
- PMA (Premarket Approval)
- QSR (Quality System Regulation)
- Post-market reporting
ISO 27001 (Information Security Management)
Managed by: information-security-manager-iso27001, isms-audit-expert
Key Areas:
- ISMS establishment and maintenance
- Risk assessment and treatment
- Security controls (Annex A)
- Continuous improvement
GDPR/DSGVO (Data Protection)
Managed by: gdpr-dsgvo-expert
Key Areas:
- Data protection impact assessment (DPIA)
- Privacy by design
- Data subject rights
- Breach notification
Regulatory Workflows
Workflow 1: New Medical Device Development
1. Risk Management (ISO 14971) → risk-management-specialist
2. QMS Process Setup (ISO 13485) → quality-manager-qms-iso13485
3. Technical Documentation (MDR) → mdr-745-specialist
4. FDA Submission → fda-consultant-specialist
5. Clinical Evaluation → regulatory-affairs-head
Workflow 2: QMS Audit Preparation
1. Internal Audit → qms-audit-expert
2. CAPA Implementation → capa-officer
3. Document Review → quality-documentation-manager
4. Management Review → quality-manager-qmr
5. Certification Audit → qms-audit-expert
Workflow 3: Data Protection Compliance
1. GDPR Assessment → gdpr-dsgvo-expert
2. ISMS Implementation → information-security-manager-iso27001
3. Security Audit → isms-audit-expert
4. Continuous Monitoring → information-security-manager-iso27001
Integration Patterns
RA/QM ↔ Engineering: Regulatory requirements inform technical design decisions
RA/QM ↔ Product: Compliance requirements shape product features and roadmap
RA/QM ↔ Security: ISO 27001 aligns with security engineering practices
Additional Resources
- RA/QM Overview:
README.md - Complete Skills Collection:
final-complete-skills-collection.md - Start Here:
START_HERE.md(if exists) - Main Documentation:
../CLAUDE.md
Last Updated: November 5, 2025 Skills Deployed: 12/12 RA/QM skills production-ready Focus: Medical device compliance (ISO 13485, MDR, FDA, ISO 27001, GDPR)