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)