ISO 13485 Readiness Scorecard
Free medical-device quality management readiness assessment using original ClearTrust guidance. Confirm applicability against the licensed standard. This score is not certification, a complete normative audit, or market authorization.
What You'll Discover
Your Readiness Score (0–100)
An educational score based on your reported implementation and evidence, with a confidence indicator.
Section Breakdown
Scores across five quality-management topic groups in this readiness questionnaire.
Up to 5 Priority Gaps
Unmet or unknown practices ranked by scoring deficit, with suggested evidence and next steps.
30/60/90-Day Action Plan
A phased quality-management plan incorporating your priority gaps.
Evidence Checklist
Specific documentation and artifacts you'll need to prepare for your audit.
Downloadable PDF Report
Comprehensive report you can share with your team and stakeholders.
Who This Is For
- •Quality leaders — Maintaining medical-device quality systems
- •Manufacturers and suppliers — Preparing quality processes and supporting evidence
- •Regulatory and operations teams — Reviewing applicable lifecycle obligations
Takes ~15 min · Results shown instantly · No account required
Disclaimer: This assessment provides an educational estimate of ISO 13485 readiness. It is not a formal audit, legal advice, or a guarantee of compliance. Actual audit results depend on your auditor's methodology, scope, and evidence quality. Your responses are stored anonymously. No personal or sensitive data is required.