Under IVDR, your lab is a manufacturer — and the answers already sit somewhere in your IFUs, validation reports, and SOPs. DocuGenius crawls your document repository, answers each Article 5(5) requirement with page-level evidence, and auto-generates deterministic rules your team can read and edit. Works standalone or feeding the regulatory platform your lab already uses.
IVDR made every lab running in-house tests a manufacturer — and the answers to its documentation requirements sit scattered across hundreds of IFUs, validation reports, and SOPs that a scarce regulatory specialist must search by hand. DocuGenius crawls the lab's own repository, auto-generates deterministic rules on pre-ready IVDR templates, and answers each requirement with page-level evidence — moving days of preparing and checking documentation to minutes of review.
Crawl the repository once, auto-generate deterministic rules, review evidence-cited answers.
IFUs, kit handbooks, instrument manuals, validation reports, SOPs, certificates. DocuGenius crawls, classifies, and indexes the whole repository — once. From then on, answers come in seconds instead of someone searching 2,000 pages.
DocuGenius auto-generates deterministic decision rules (DMN) from your documentation — Annex VIII classification, GSPR mapping, intended-purpose consistency — on top of pre-ready IVDR templates our team ships with the platform. Your RA team reads and edits every rule; nothing is a black box.
Every answer carries source document, page, and quoted passage — ready to flow into your In-House File or into the questionnaire of the regulatory platform your lab already works in. Where the repository holds no answer, DocuGenius says so instead of guessing.
Days → min
Preparing and cross-checking a documentation section drops from days of manual searching to minutes of review.
<1 day
Pilot up with pre-ready IVDR templates and Article 5(5) structure loaded.
100%
Of answers rule-traced and evidence-cited — deterministic, not freehand-generated.
A 15-minute walkthrough on a real document — yours or ours. Pilot environment live in under a day.
Generic tools store and route documents. They don't answer regulatory questions from them.
DocuGenius
MDCG 2023-1 field lists, Annex VIII classification rules, and public-declaration structure ship pre-loaded — pilot starts answering on day one.
Generic IDP / QMS suites
Generic extraction; you bring the regulatory structure yourself.
DocuGenius
Decision rules are generated from your own documentation as editable DMN — your RA team reads, edits, and owns the logic.
Generic IDP / QMS suites
Opaque model output, or rule changes that need a services engagement.
DocuGenius
Every answer cites source document, page, and quoted passage — auditor-ready, and abstains when your repository holds no answer.
Generic IDP / QMS suites
Search returns documents, not answers; someone still reads 2,000 pages.
Share your use case, we'll come prepared
What you'll get
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