2025 Updated Comprehensive ISO 13485:2016 Checklist
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“This checklist helped us identify 23 gaps in our QMS documentation before our Stage 1 NB audit.”
– Regulatory Director, Class IIb Manufacturer
“Saved us months of work in preparing for MDR compliance. Worth every penny.”
– QA Manager, Startup
50+ EU MDR Transition Projects
20+ Technical File Reviews
“We’ve included every critical EU MDR requirement we’ve seen cited in QMS audits—so you can identify compliance gaps before they become findings.”
The only checklist focused purely on EU MDR QMS requirements with direct ISO 13485 mapping.
Covers: PPRC • Economic Operators • UDI • PMS • Vigilance • DoC • Classification and more
Includes detail audit guidance for 27 specific QMS findings from actual NB audits.
Targets: PPRC qualifications • PMS procedures • Labeling controls • NB communication • vigilance and more
Pre-formatted evidence columns with risk-class specific implementation tips.
Includes: Y/N/N/A assessment • Doc reference fields • Sample records • NB expectations
QMS-first approach: While we reference technical requirements, this checklist focuses on implementing processes to achieve and maintain compliance.
Note: This checklist does not assess technical file content but ensures your QMS has processes to generate and maintain compliant documentation.
| Feature | Our EU MDR Checklist | Basic Templates |
|---|---|---|
| 2025 Amendment Coverage | ✅ Full coverage | ❌ Missing updates |
| Technical Documentation Depth | ✅ 28 specific checks | ⏳ 8-10 generic checks |
| Clinical Evaluation Guidance | ✅ Article 61 + Annex XIV | ⏳ Basic requirements only |
| PMS System Requirements | ✅ Articles 83-86 detailed | ⏳ Minimal coverage |
| Risk-Class Specific Advice | ✅ Class I-III tailored | ❌ One-size-fits-all |
Specialized tools for Full QMS compliance – no templates, just proven audit resources.
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Need ISO 13485 too?
View our ISO 13485 Internal Audit Checklist here.
Note: This is a QMS-focused solution. For technical documentation templates,
contact our team for custom assistance.
