QM Audit Checker

Quality Managers & Regulatory Affairs Teams preparing for QMS audits.

Problem

Every audit brings uncertainty. The stress of uncovering unexpected findings and non-conformities is exhausting — and manual QMS reviews are prone to errors. They're slow, inconsistent, and limited by what reviewers already know.

Solution

CertHub simulates a real QMS audit, flags non-conformities against ISO 13485/MDR Annex IX/FDA requirements, and delivers a corrective actions plan, freeing your team while you keep full control over every decision.

More ressources for what matters...

0h

saved on manual reviews

0%

faster review without sacrificing scientific integrity

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traceability throughout your QMS

Covering the four stages of QMS audit simulation

Scope & Standards Definition

Define your device classification, applicable standards (ISO 13485, MDR Annex IX, FDA 21 CFR Part 820, ISO14791, etc.) 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.

Audit-Ready Report & Corrective Actions Plan

CertHub instantly drafts a full assessment report — severity-ranked findings, specific corrective actions guidance, and a traceable audit trail. Expert guidance included.

We’ll walk you through...

Let's find out more about CertHub and see the QM Audit Checker in action.

CertHub offers AI-fueled software solutions for Technical Documentation, QMS and Design Control - tailored to the MedTech industry.