MedTech SMEs and startups preparing for global QMS audits, and TechDoc submissions and Gap Analysis
Hidden gaps and incomplete documentation cause delays and exploding costs
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.
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.)
CertHub helps you uncover documentation gaps upfront and plan effectivly to meet MDR/IVDR standards before its too late.
CertHub lets you monitor what's missing and outdated for every single submission/dossier you have.
We simulate an auditor's perspective with structural and semantic checks, which can be combined with a management review.
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.
Let's find out more about CertHub and see the AI Conformity Checker in action.
CertHub offers AI-fueled software solutions for Technical Documentation, QMS and Design Control - tailored to the MedTech industry.
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