DocuGeniusDocuGenius
EU MDR · Annex II · GSPR · DoC

MDR compliance software for technical files,
pre-validated against Annex II.

DocuGenius automates EU MDR technical documentation. Gap-flag GSPR coverage, auto-structure your Annex II submission, ship audit-traced output your Notified Body can sign off on.

From €500/month
EU on-prem available
Pilot under 1 day
From €500/month

See DocuGenius read a real document

Watch DocuGenius extract data, apply your rules, and log every decision live, on a sample document.

Built by ITQuarks (EU)
EU on-premise available
GDPR-aligned
ISO-aligned controls
How it works

Annex II compliance, end-to-end

Upload your technical file, run rule-based extraction, ship a Notified-Body-ready submission with the full audit trace.

1

Ingest your technical file

Drop in IFU, DoC, GSPR checklist, design history files. DocuGenius classifies each section and pre-fills Annex II structure.

2

Run no-code MDR rules

Agentic AI cross-checks GSPR coverage, flags gaps, and produces structured output your reviewers can sign off on.

3

Audit-traced output

Every decision is versioned and traceable. Hand the submission to the Notified Body with confidence.

Outcomes

What teams report

<1 day

New rule onboarded in pilot - no code release required.

35–50%

Time saved on technical-file preparation per submission.

0

Vendor lock-in. Multi-LLM routing optimises cost, accuracy, latency.

Differentiators

Why DocuGenius vs. ABBYY / Hyperscience / horizontal IDP

Generic IDP wasn't built for Annex II structure or Notified-Body audit expectations.

Annex II governance

Pre-loaded MDR Annex II structure, GSPR mapping, DoC templates.

Generic IDP / QMS suites

Generic extraction; you bring the regulatory structure yourself.

No-code rule edits

Reg-affairs teams update compliance logic without engineering.

Generic IDP / QMS suites

Workflow tweaks require services engagements or QMS admin.

EU on-premise

Available on day one. Your data stays in your EU tenant.

Generic IDP / QMS suites

Mostly US-cloud; on-prem available only at enterprise tier.

Common questions

Frequently asked

Honest answer: only if your GSPR coverage gaps take 3+ weeks per submission to close manually. QMS and generic IDP tools store and route documents. They don't read your IFU against GSPR and flag the missing risk-control evidence. That's the gap. If your existing stack already does that well, you don't need us.

Get a 5-min walkthrough on your documents

Share your use case, we'll come prepared

  • We'll walk through DocuGenius on a real document, yours or ours
  • From signed contract to live in under 2 weeks
  • Every decision logged and rule-traceable for audit
  • Your data stays yours - we never train on it

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