2025 Updated Comprehensive ISO 13485:2016 Checklist
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“Cut our findings by 80% after implementing this checklist.”
– Quality Manager, Class II Manufacturer
“Passed our Notified Body audit with zero findings for the first time.”
– Director of QA, Startup
20+ Years in Medical Device Compliance
6+ Years as Notified Body Lead Auditor
“This checklist includes every finding I’ve encountered in two decades of audits—so you can catch gaps before inspectors do.”
Organized by ISO 13485 requirements with emphasis on areas most frequently cited in audits.
Clear columns for documenting conformance (Y/N/N/A) and evidence references.
Editable Word version lets you add specific notes or exclude non-applicable sections.
Pair this checklist with expert guidance to eliminate findings completely.
80%
Reduction in findings
100%
Of clients pass surveillance audits
The last checklist you’ll ever need to buy
$645
Save $50
| Feature | Our Solution | Basic Templates | Competitors |
|---|---|---|---|
| Price | $248 | $99–$150 | $250–$400 |
| Formats | ✅ PDF + Word | PDF only | PDF only |
| Team License | ✅ Unlimited | ❌ Single user | ⏳ Extra fees |
| NB Audit Insights | ✅ 50+ key insights | ❌ None | ⏳ Limited |
| Free Updates | ✅ 1 year included | ❌ No updates | ⏳ Paid updates |
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