Multi-Product Compliance: Scaling Complexity

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Portfolio-wide gap analysis: Identify missing or outdated documents across multiple product lines before audits or submissions.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.