Stop duplicating work across product lines. CertHub streamlines documentation, evaluations, and audits at scale.
Legacy document transfer: Import Word and Excel files from multiple products — AI extracts and structures the content into a unified knowledge model.
Cross-product reuse: Update shared data once (e.g., risk, intended purpose) and apply it instantly across all devices and submissions.
Instant updates: Changes in product versions cascade automatically into every dependent document and submission.
Audit-ready packages: Generate complete TechDocs for all products at the click of a button, fully traceable back to the source.
Portfolio-wide gap analysis: Identify missing or outdated documents across multiple product lines before audits or submissions.
Centralized progress tracking: See the readiness status of every device in one dashboard — what’s complete, what’s missing, and where to act.
Audit simulations at scale: Run AI-driven checks across your QMS and submissions portfolio to catch issues early.
Final submission checks: Validate dossiers for multiple devices against Notified Body expectations before handoff.
Multi-standard coverage: Checks conformity against ISO 13485, ISO 13495, ISO 14971, IEC 62366, and EN ISO 15189, all in a single workflow
Root-cause diagnosis: Pinpoints gaps and non-conformities in your QMS documentation before an external auditor does, so your team can act early.
Four-stage audit simulation: Walks you through scope definition, document upload, simulated audit, and a full remediation plan with risk analysis.
Audit-ready reports Generates structured findings, corrective actions, and risk assessments ready to present to certification bodies.
Legacy document transfer: Import Word and Excel files from multiple products — AI extracts and structures the content into a unified knowledge model.
Cross-product reuse: Update shared data once (e.g., risk, intended purpose) and apply it instantly across all devices and submissions.
Instant updates: Changes in product versions cascade automatically into every dependent document and submission.
Audit-ready packages: Generate complete TechDocs for all products at the click of a button, fully traceable back to the source.
Portfolio-wide gap analysis: Identify missing or outdated documents across multiple product lines before audits or submissions.
Centralized progress tracking: See the readiness status of every device in one dashboard — what’s complete, what’s missing, and where to act.
Audit simulations at scale: Run AI-driven checks across your QMS and submissions portfolio to catch issues early.
Final submission checks: Validate dossiers for multiple devices against Notified Body expectations before handoff.
Multi-standard coverage: Checks conformity against ISO 13485, ISO 13495, ISO 14971, IEC 62366, and EN ISO 15189, all in a single workflow
Root-cause diagnosis: Pinpoints gaps and non-conformities in your QMS documentation before an external auditor does, so your team can act early.
Four-stage audit simulation: Walks you through scope definition, document upload, simulated audit, and a full remediation plan with risk analysis.
Audit-ready reports Generates structured findings, corrective actions, and risk assessments ready to present to certification bodies.
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