Conformity Checker AI & Gap Analysis

MedTech SMEs and startups preparing for global QMS audits, and TechDoc submissions and Gap Analysis

Problem

Hidden gaps and incomplete documentation cause delays and exploding costs

Solution

From gap analysis to submission, CertHub supports your team with strategic gap analysis, live completeness tracking, and intelligent pre-audit and submission checks – ensuring your documentation is created quickly, accuratly, and ready to defend.

More ressources for what matters...

0min

to know exactly the quality and gaps of your current documents

audit and conformity assessment readiness at any time

clearer what is the current status of your QMS and Technical Documentation for a specific jurisdiction (EU/FDA, etc.)

What's inside

Gap Analysis Assistant

CertHub helps you uncover documentation gaps upfront and plan effectivly to meet MDR/IVDR standards before its too late.

Completeness & Progress Tracker

CertHub lets you monitor what's missing and outdated for every single submission/dossier you have.

QMS Ready-for-Audit Checker

We simulate an auditor's perspective with structural and semantic checks, which can be combined with a management review.

TechDoc Submission Checker

Our AI checks your data for content and completeness against general safety and performance requirements, aligned with notified body expectations, and generates an evaluation report.

We’ll walk you through...

Let's find out more about CertHub and see the AI Conformity Checker in action.

Book a Demo