c6206efc49
- CLAUDE.md: engineering-team 26→29, engineering 30→35, ra-qm 12→13 - engineering-team/CLAUDE.md: add azure-cloud-architect, gcp-cloud-architect, security-pen-testing - ra-qm-team/CLAUDE.md: add soc2-compliance (12→13) - docs/getting-started.md: update Available Bundles table - docs/index.md: update domain skill count cards Official skill count remains 205. Co-Authored-By: Claude Opus 4.6 (1M context) <noreply@anthropic.com>
155 lines
4.4 KiB
Markdown
155 lines
4.4 KiB
Markdown
# Regulatory Affairs & Quality Management Skills - Claude Code Guidance
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This guide covers the 13 production-ready RA/QM compliance skills for HealthTech/MedTech companies.
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## RA/QM Skills Overview
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**Strategic Leadership (2 skills):**
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- regulatory-affairs-head - RA strategy, regulatory intelligence, authority relations
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- quality-manager-qmr - QMS oversight, management review, quality culture
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**Quality Systems (3 skills):**
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- quality-manager-qms-iso13485 - ISO 13485 compliance, process management
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- capa-officer - CAPA system management, root cause analysis
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- quality-documentation-manager - DHF, DMR, DHR management
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**Risk & Security (2 skills):**
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- risk-management-specialist - ISO 14971 compliance, risk analysis
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- information-security-manager-iso27001 - ISO 27001, data protection, ISMS
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**Regulatory Specialists (2 skills):**
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- mdr-745-specialist - EU MDR 2017/745 compliance, technical documentation
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- fda-consultant-specialist - FDA 510(k), PMA, QSR compliance
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**Audit & Compliance (4 skills):**
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- qms-audit-expert - Internal audits, ISO 13485 certification
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- isms-audit-expert - ISO 27001 audits, security assessments
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- gdpr-dsgvo-expert - GDPR/DSGVO compliance, data privacy
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- soc2-compliance - SOC 2 Type I/II compliance, trust service criteria, audit readiness
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**Total:** 13 specialized compliance skills for medical device industry
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## Compliance Frameworks
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### ISO 13485 (Medical Device Quality Management)
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**Managed by:** quality-manager-qms-iso13485, qms-audit-expert
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**Key Areas:**
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- Management responsibility
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- Resource management
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- Product realization
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- Measurement, analysis, improvement
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**Tools:**
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- QMS process mapping
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- Document control systems
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- Change management workflows
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### ISO 14971 (Medical Device Risk Management)
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**Managed by:** risk-management-specialist
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**Key Areas:**
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- Risk analysis and evaluation
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- Risk control measures
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- Residual risk evaluation
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- Risk management review
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**Tools:**
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- Risk assessment templates
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- FMEA/FMECA analysis
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- Risk-benefit analysis
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### MDR 2017/745 (EU Medical Device Regulation)
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**Managed by:** mdr-745-specialist
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**Key Areas:**
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- Technical documentation (Annex II, III)
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- Clinical evaluation (Annex XIV)
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- Post-market surveillance
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- UDI (Unique Device Identification)
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### FDA Regulations (US Medical Device Compliance)
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**Managed by:** fda-consultant-specialist
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**Key Areas:**
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- 510(k) premarket notification
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- PMA (Premarket Approval)
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- QSR (Quality System Regulation)
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- Post-market reporting
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### ISO 27001 (Information Security Management)
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**Managed by:** information-security-manager-iso27001, isms-audit-expert
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**Key Areas:**
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- ISMS establishment and maintenance
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- Risk assessment and treatment
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- Security controls (Annex A)
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- Continuous improvement
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### GDPR/DSGVO (Data Protection)
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**Managed by:** gdpr-dsgvo-expert
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**Key Areas:**
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- Data protection impact assessment (DPIA)
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- Privacy by design
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- Data subject rights
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- Breach notification
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## Regulatory Workflows
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### Workflow 1: New Medical Device Development
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```
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1. Risk Management (ISO 14971) → risk-management-specialist
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2. QMS Process Setup (ISO 13485) → quality-manager-qms-iso13485
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3. Technical Documentation (MDR) → mdr-745-specialist
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4. FDA Submission → fda-consultant-specialist
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5. Clinical Evaluation → regulatory-affairs-head
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```
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### Workflow 2: QMS Audit Preparation
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```
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1. Internal Audit → qms-audit-expert
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2. CAPA Implementation → capa-officer
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3. Document Review → quality-documentation-manager
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4. Management Review → quality-manager-qmr
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5. Certification Audit → qms-audit-expert
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```
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### Workflow 3: Data Protection Compliance
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```
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1. GDPR Assessment → gdpr-dsgvo-expert
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2. ISMS Implementation → information-security-manager-iso27001
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3. Security Audit → isms-audit-expert
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4. Continuous Monitoring → information-security-manager-iso27001
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```
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## Integration Patterns
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**RA/QM ↔ Engineering:** Regulatory requirements inform technical design decisions
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**RA/QM ↔ Product:** Compliance requirements shape product features and roadmap
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**RA/QM ↔ Security:** ISO 27001 aligns with security engineering practices
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## Additional Resources
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- **RA/QM Overview:** `README.md`
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- **Complete Skills Collection:** `final-complete-skills-collection.md`
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- **Start Here:** `START_HERE.md` (if exists)
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- **Main Documentation:** `../CLAUDE.md`
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---
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**Last Updated:** November 5, 2025
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**Skills Deployed:** 13/13 RA/QM skills production-ready
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**Focus:** Medical device compliance (ISO 13485, MDR, FDA, ISO 27001, GDPR)
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