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Technical Documentation Generation in Matrix Req

Generate, review, archive, and sign your technical documentation — directly from your project data, in the format you need.

Matrix Requirements
The challenge
Our solution

Producing technical documentation is slow, error-prone, and hard to keep current

Documentation that writes itself — from your live project data

  • Manual assembly

    • Pulling together requirements, test results, and risk data from different sources into a single document takes significant time and effort.

  • Generate documents automatically from

    • your live requirements, test results, and design items.

  • Version control issues

    • Keeping documents in sync with the latest project data is a constant challenge — especially across large teams.

  • Stay in control

    • with structured review workflows and FDA 21 CFR Part 11 compliant electronic signatures.

  • Slow review and sign-off

    • Managing review workflows and electronic signatures across multiple documents adds delays to already tight timelines.

  • Archive with confidence

    • freeze documents at any point to preserve their content for regulatory submissions.

    The challenge

    Producing technical documentation is slow, error-prone, and hard to keep current

  • Manual assembly

    • Pulling together requirements, test results, and risk data from different sources into a single document takes significant time and effort.

  • Version control issues

    • Keeping documents in sync with the latest project data is a constant challenge — especially across large teams.

  • Slow review and sign-off

    • Managing review workflows and electronic signatures across multiple documents adds delays to already tight timelines.

    Our solution

    Documentation that writes itself — from your live project data

  • Generate documents automatically from

    • your live requirements, test results, and design items.

  • Stay in control

    • with structured review workflows and FDA 21 CFR Part 11 compliant electronic signatures.

  • Archive with confidence

    • freeze documents at any point to preserve their content for regulatory submissions.

    Core Features

    Purpose-built tools to generate, manage, and sign your medical device technical documentation.

    Technical File GenerationOrganize your Technical File according to available project templates (CE mark, DHF/DMR) or your preferred structure. Link document versions to Technical File versions and export a complete ZIP archive of all selected documents as PDF files.
    Document CreationBuild documents from existing templates or from scratch using a modular approach. Sections can be automatically populated with live project data, combining static content (rich text, tables, tick boxes) with dynamic content (hyperlinks, matrix tables).
    Document Review & Sign-OffSet up review workflows with automated flags and two-click review requests. Once content is approved, apply electronic signatures fully compliant with FDA 21 CFR Part 11.
    Technical Document GenerationExtract, analyse, and export project data as PDF, Word, or HTML files. Design your document structure, choose the content to include, and generate audit-ready documentation in minutes.

    • Flexible Structure: Select sections such as history tables, trace tables, and item lists.

    • Targeted Content: Specify exactly which requirements, test results, or design items to include.

    • Multiple Formats: Export as Word, PDF, HTML, or Excel for custom tables.

    Hear from our customers

    With Matrix Req, we avoid all the challenges of using manual or custom-developed tools. Instead, we get a purpose-built solution that’s designed by medical device experts, enabling much faster ISO 13485 compliance.”

    François Audéon, Chief Technology Officer

    Matrix One is trusted by 500+ Life Sciences & Medical Device Companies