Pre Certification: Bringing your first medical device on the market

From zero to hero in weeks: Go from no documentation to a full CE submission package faster than ever.

Guided onboarding: Our superb customer success guides you step by step through what you have to do, in person and with on-demand tutorials.

Submission-ready documentation: Automatically generated, fully traceable, and aligned with regulatory expectations.

Expert-reviewed logic: Templates and decision flows are backed by regulatory experts for peace of mind.

Fraction of costs: Achieve higher outcome with fewer costs than every before thanks to newest technologies and the right experts jumping if when really needed.

Generate TechDocs instantly: Create full MDR/IVDR submissions with one click — from Risk Files to Clinical Evaluations.

Start from scratch: Use our Knowledge Model for new products or let AI convert Word/Excel chaos into structured documentation.

Edit once, update everywhere: Change a single element, and updates flow automatically into every related document and submission.

Full traceability built in: Every paragraph links back to its source, ensuring transparency and audit confidence.

Always know what’s missing: Dashboards show completeness, gaps, and quality signals — so you submit only when ready.

Spot gaps early: Run an AI-powered gap analysis to identify missing or weak documentation before you invest time in writing.

Track progress live: Monitor what’s complete, missing, or outdated across all submission modules with real-time dashboards.

Simulate audits: Test your QMS against an AI-driven audit checker that highlights structural and semantic issues before the real thing.

Check submissions before handoff: Upload your TechDoc package and get a final AI review against Notified Body expectations, reducing the risk of rejection.

De-risk certification: Fix problems before they cause delays, costly rework, or failed submissions — and enter your next audit with confidence.

Multi-standard coverag: 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.