Quality Managers, Regulatory Affairs Teams and MedTech SMEs preparing for QMS audits
Problem
You don't know if you'll pass the ISO 13485 audit, until it's too late and findings are already on record. Manual QMS reviews are slow, inconsistent, and biased towards what reviewers already know.
Solution
CertHub simulates a real QMS audit, flags every non-conformity against ISO 13485, MDR Annex IX and FDA requirements, and delivers a prioritized remediation plan, freeing your team while you keep full control over every decision.
More ressources for what matters...
0h
saved on manually reviewing papers
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faster review without sacrificing scientific integrity
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tracability of all papers used
Covering the four stages of QMS audit simulation
Scope & Standard Definition
Define your device classification, applicable standard (ISO 13485, MDR Annex IX, FDA 21 CFR Part 820), and the QMS modules in scope, we guide you through every step so the simulation matches your real-world context precisely.
QMS Document Upload
Upload your SOPs, work instructions, procedures, and records. CertHub accepts PDFs, Word files, Excel sheets, and scanned documents, no reformatting, no manual indexing required.
Automated Audit Simulation
CertHub uses AI agents to apply structural and semantic checks across your entire QMS — clause by clause against the applicable standard, identifying missing links, contradictions, and non-conformities exactly as a real auditor would.
CertHub instantly drafts a full assessment report — severity-ranked findings, specific remediation guidance per clause, and a fully traceable audit trail. Expert guidance included. Ready for management review or notified body submission.
We’ll walk you through...
Let's find out more about CertHub and see the QM Audit Conformity Checker in action.
