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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.
The challenge
Our solution
Core Features
Purpose-built tools to generate, manage, and sign your medical device technical documentation.
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.
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 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.
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
