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.
Building or remediating an MDR technical file means reconciling Annex II and III evidence across dozens of documents by hand. DocuGenius reads your technical documentation against the MDR requirements and surfaces the gaps in days, not the weeks a manual pre-validation takes.
Upload your technical file, run rule-based extraction, ship a Notified-Body-ready submission with the full audit trace.
Drop in IFU, DoC, GSPR checklist, design history files. DocuGenius classifies each section and pre-fills Annex II structure.
Agentic AI cross-checks GSPR coverage, flags gaps, and produces structured output your reviewers can sign off on.
Every decision is versioned and traceable. Hand the submission to the Notified Body with confidence.
<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.
A 15-minute walkthrough on a real document — yours or ours. Pilot environment live in under a day.
Generic IDP wasn't built for Annex II structure or Notified-Body audit expectations.
DocuGenius
Pre-loaded MDR Annex II structure, GSPR mapping, DoC templates.
Generic IDP / QMS suites
Generic extraction; you bring the regulatory structure yourself.
DocuGenius
Reg-affairs teams update compliance logic without engineering.
Generic IDP / QMS suites
Workflow tweaks require services engagements or QMS admin.
DocuGenius
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.
Share your use case, we'll come prepared
What you'll get
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