21 CFR Part 820 vs
ISO 13485:2016
Evaluate your QMS compliance across 32 sections with this guided gap assessment. Get a real-time compliance score and identify critical gaps in minutes.
📋 How It Works
For each QMS section, rate your current compliance status across both standards. The tool calculates a real-time gap score and surfaces specific findings for your team.
🎯 What You'll Get
A prioritized list of gaps, a compliance score per section, drop-off tracking across sections, and an exportable CSV report for management review. At the end, we'll ask for your details so we can send you a copy.
⚡ Scoring Guide
Fully Compliant — Documented procedure fully meets the requirement.
Partial — Partial coverage; gaps exist.
Gap — Requirement not addressed.
⚠️ Important Notice
This is a self-assessment tool for internal planning only. It does not constitute an official audit, regulatory certification, or legal compliance opinion. Always engage a qualified regulatory expert for formal compliance determinations.
Almost There
You've completed the assessment. Please share a few details so we can send you a copy of your results and follow up with tailored guidance.
⚠️ Self-Assessment Disclaimer: These results are generated from your own responses and are intended for internal planning and prioritisation purposes only. This tool does not constitute an official regulatory audit, ISO 13485 certification assessment, FDA inspection readiness determination, or legal compliance opinion. Findings should be reviewed with a qualified regulatory affairs or quality management professional before any compliance decisions are made. EasyQ Solutions accepts no liability arising from actions taken based solely on this self-assessment.
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Sections with Partial Gaps
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Sections with Critical Gaps
📊 Section Engagement Tracker — shows which sections were visited and time spent (for internal analytics)
| Section |
21 CFR Reference |
ISO 13485 Reference |
21 CFR Status |
ISO 13485 Status |
Score |
Risk |