Technical Documentation Generation in Matrix Req
Generate, review, archive, and sign your technical documentation — directly from your project data, in the format you need.
For taking a demo with our team.
The challenge
Producing technical documentation is slow, error-prone, and hard to keep current
For medical device teams, technical documentation is never truly "done." Requirements change, tests are updated, and regulatory standards evolve — making it difficult to keep documents accurate, consistent, and audit-ready. Manually assembling documentation from multiple sources is time-consuming and increases the risk of errors and version conflicts.
- Manual assemblyPulling together requirements, test results, and risk data from different sources into a single document takes significant time and effort.
- Version control issuesKeeping documents in sync with the latest project data is a constant challenge — especially across large teams.
- Slow review and sign-offManaging 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
Matrix Req's document control features let you design document templates once and generate accurate, up-to-date documentation automatically from your project database. Whether you need a PDF for submission, a Word file for review, or an HTML export, your documents are always grounded in real, traceable project data.
- Generate documents automatically fromyour live requirements, test results, and design items.
- Stay in controlwith structured review workflows and FDA 21 CFR Part 11 compliant electronic signatures.
- Archive with confidencefreeze 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 Generation
Organize 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 Creation
Build 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-Off
Set 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 Generation
Extract, 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.
- Select sections such as history tables, trace tables, and item lists
- Specify exactly which requirements, test results, or design items to include
- 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
