Manage ISO and regulatory compliance
cs-quality-regulatoryskillsetup L3★17,464
alirezarezvani/claude-skills ↗What it does
Guide ISO 13485 QMS, MDR compliance, and GDPR audits
Best for
Structured regulatory strategy and audit preparation for medical device and healthcare companies.
Inputs
- · audit scope
- · device classification
- · processing activities
Outputs
- · gap analysis
- · compliance checklist
- · audit readiness report
Requires
- · Quality Manager
- · Regulatory Affairs
- · CAPA Officer
- · ISMS Audit Expert
Preconditions
ISO standard context known, device classification applicable
Failure modes
- · Incomplete documentation
- · Audit scope narrower than QMS coverage
- · GDPR legal basis not mapped to activities
Trust signals
- · 3 skill domains listed with example tools
- · Core workflows enumerated with steps
- · Output standards section with traceability
- · Success metrics with specific thresholds