Get a free, AI-powered ISO 13485 & FDA 21 CFR 820 gap analysis in minutes. Identify critical risks before the auditor does.
Identify potential non-compliance risks in your Quality Management System against ISO 13485. This assessment focuses on 5 critical clauses that commonly align with FDA 21 CFR 820 (QSR) audit expectations, helping highlight areas where audit gaps may exist.
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Securely upload your QMS procedures or technical files. We support PDF and standard regulatory document formats.
Our AI scans content against ISO 13485:2016 clauses and specific FDA 21 CFR 820 audit expectations.
Get an instant readiness score and findings detailing exactly where non-compliance risks may exist.