Post Certification: Living with Compliance

One-click updates: When your product changes, all related documents are updated instantly across the submission package.

Live compliance status: Dashboards show what’s complete, missing, or outdated — so you always know where you stand before an audit.

Traceability guaranteed: Every update is tracked back to its source, ensuring transparency for surveillance audits and recertifications.

Reuse across versions: Eliminate redundant work by reusing structured data and templates across product updates.

Always audit-ready: Generate updated, submission-ready documentation at any time — with full confidence nothing is forgotten.

Spot gaps early: Automated completeness and conformity checks highlight issues before they become audit risks.

Track progress live: See what’s ready, missing, or outdated across all TechDoc and QMS modules.

Simulate audits: AI-powered reviews replicate auditor checks to identify structural and semantic issues.

Validate submissions: Run a final check against Notified Body expectations before handoff.

Reduce risk: Avoid delays, costly rework, and failed certifications by fixing issues early.

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.

Cut prep time by up to 57 h: What normally takes weeks of manual review can now be completed in a fraction of the time, letting your team focus on quality, not paperwork.