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✦ MDR Compliance Platform · Beta

Navigate MDR Compliance
with Precision

The only platform built around what Notified Bodies normally ask in an audit. Fill the Get Ready for Audit template with AI-guided assistance, track every gap, and arrive at your certification audit fully prepared.

Join the Beta — Free Until Oct 31 Try MDR Bot Expert See How It Works

Audit Readiness Score

● Live
Device CardioMonitor X1 Class IIa · Rule 3
Requirements 340 of 360 mapped Annex II & III
Top Gaps Clinical eval. · Risk mgmt · PMS
12
Compliant
3
Partial
1
Gap
94%
Readiness Score
AI-guided gap detection
Cross-market readiness

Platform Overview

Built Around What Auditors Ask

Every requirement in the Get Ready for Audit template maps directly to what Notified Bodies examine during certification audits.

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Get Ready for Audit Template

A structured, audit-proven template built from real notified body expectations. Fill each section with guided assistance.

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AI-Guided Gap Detection

Upload your existing documentation. Our engine analyzes it against the full scope of MDR requirements and flags gaps automatically.

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Cross-Market Readiness

Your audit preparation extends beyond Europe. See how your documentation measures up for global regulators.

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Evidence Linking

Link each audit requirement directly to your controlled documents. Your evidence trail is ready before the auditor arrives.

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Progress Dashboard

See your readiness at a glance. Know exactly what is covered, what is partial, and what needs attention.

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Document Generation

Generate CER, PSUR, SSCP, and PMCF reports from structured templates. Save hours of manual document work.

The Approach

One Template, Every Audit Requirement

Stop guessing what auditors will ask. Our template covers the full scope of what Notified Bodies examine during MDR certification audits.

📋 Company & Device Information

  • Manufacturer details, PRRC, AR
  • Device classification, EMDN code, rule
  • Conformity assessment route
  • UDI assignment and EUDAMED registration
  • SRN and actor registration status

🔍 QMS & Technical Documentation

  • ISO 13485:2016 quality management system
  • Annex II — device description, design, manufacturing
  • Annex I — GSPR compliance matrix
  • Risk management per ISO 14971
  • Labelling, IFU, DoC, CE marking

READINESS BREAKDOWN — CARDIO MONITOR X1

Company & Device Info All fields completed covered
QMS (ISO 13485 + MDR) 18 of 19 sections mapped covered
Technical Documentation Annex II + III evidence linked partial
Clinical Evaluation CER v2.3 (2026-03-15) Gap: equivalence access
📖 Recommended action: Equivalence requires documented access to equivalent device technical documentation. Verify you have signed data access agreements for all reference devices. View guidance →

Your Path to Certification

From Assessment to Audit-Ready

A clear path from where you are today to walking into your certification audit with confidence.

1

Map Your Status

Work through every audit requirement and link your evidence in the Get Ready for Audit template.

2

Gaps Identified

AI flags what is missing, partial, or needs improvement — prioritized by impact on your audit.

3

Close the Gaps

Guided actions to bring every requirement to full compliance before the auditor arrives.

4

Audit-Ready

Complete evidence package ready for your notified body review. No surprises, no last-minute fire drills.

Pricing

Free During Public Beta

We are in active development. Your feedback matters more than revenue right now. Use everything free until we exit beta.

Active — Public Beta
⚡ Testing Phase — Your feedback drives our roadmap
Cygnus Health Platform
Free
Free until October 31, 2026
After beta: from 599 €/mo · You get 6 months free by joining now
Full access to every feature. No credit card required. No time limit during beta.
  • Complete Get Ready for Audit template
  • AI-guided gap detection
  • Evidence linking & management
  • Real-time readiness scoring
  • Cross-market readiness (EU, FDA, & more)
  • Document generation (CER, PSUR, SSCP)
  • Team collaboration
  • Priority feedback channel
Join Beta — Get 6 Months Free

Why Join the Beta?

Shape the Platform, Lock in Free Access

Early adopters get 6 months free when we launch paid plans. Your feedback directly determines what we build next.

🎁
6 Months Free
After Beta Launch
📝
Direct Line to
Our Product Team
🚀
Early Access to
New Features
🎯
Influence the
Product Roadmap
Join the Beta Now

Platform Modules

Everything You Need, Nothing You Don't

Six integrated modules — use them together or standalone.

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Audit Template

Complete Get Ready for Audit template across all MDR sections

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Gap Detection

AI-powered analysis that flags missing and partial requirements

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Evidence Manager

Link controlled documents to every audit requirement

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Dashboard

Real-time readiness scoring and section-by-section breakdown

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Document Gen

Generate CER, PSUR, SSCP from structured templates

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Global Markets

Cross-market readiness for EU, FDA, SAHPRA, TFDA, and more