Technical documentation generation with Matrix Requirements.

Document control in Matrix Requirements® allows you to extract, analyse, archive, and electronically sign project data as PDF, Word, or HTML files.

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A smarter way to generate technical documentation customize with Matrix Requirements

Analyse, archive, and electronically sign project data as PDF, Word, or HTML files.

Technical doc generation

Document control in Matrix Requirements® allows you to extract, analyse, archive, and electronically sign project data as PDF, Word, or HTML files. With Controlled Documents, you can:

  • Design document structure: select specific sections to include, such as history table, scope, purpose, trace tables, and lists of items to automatically fetch design item information from the project database.

  • Choose content: specify the data to include, such as requirements from a specific folder or test results for chosen specifications.

  • Download and review: generate and review documents in Word, PDF, or HTML format.

  • Archive securely: archive documents to preserve their content, ensuring it remains unchanged even if data in the database is updated.

  • Sign electronically: apply an electronic signature compliant with FDA 21 CFR Part 11.

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Documents creation

Creating a new document is easy: you can either start from an existing template (for instance, approved within your QMS) or from scratch.

  • Documents can be built like building blocks which can be connected to the project.

  • Sections can be automatically populated with the latest project data.

  • Within documents, you can manage the content by sections and edit the content with static content (rich text, tick boxes, drop-down, tables, etc.) as well as dynamic content (hyperlinks related to items, matrix tables, etc.).

  • Each controlled document can be frozen at any time. Define default templates for new controlled documents.

  • Once your content is ready, you can preview the result and then export in your desired format. Reports and documents can be created as HTML, Word, PDF, or Excel for custom tables.

Documents review & sign-off

  • You can set up a workflow to mark items with a review flag. A change to the item can automatically reset this flag.

  • You can create review packets for different review types per category to make requesting reviews as easy as two clicks directly from the item in order to quickly perform and document design and quality process reviews.

  • After review, documents can be electronically signed. We fully support compliance with FDA 21 CFR part 11 for electronic records including electronic signatures.

Technical file generation

In Matrix Requirements®, you can organize your Technical File documentation in an easy way according to the available project templates (CE mark, DHF/DMR…) or to your preferred structure.

  • The applicable versions of the documents can be traced and linked back to a Technical File version.

  • Once the version is finalized, you can create a package to automatically export all the file (.ZIP archive) containing all the selected documents as PDF files.

Accelerate time to market with Matrix Requirements

Global ReachOur customers sell their devices across all 6 continents and in multiple jurisdictions. Matrix Requirements stays ahead of changing global compliance needs so you don't have to.
Regulatory & Industry Standards CoveredAchieve compliance to regulatory and industry standards across design & development, security, and privacy arenas with a Design Control & QMS solution that puts compliance at the center of your product development.

Hear from our customers

"Matrix Requirements addressed all our core technical requirements, and we were also very impressed with the Matrix Requirements team.”

Erika Andreetto, Project Manager, Tecres

Hear from our customers

Roche

"With Matrix Requirements, we can generate PDF documents in the same format as before in a highly automated way, improving our team’s efficiency by an estimated 60%."

Hans-Jurgen Schneider, Project Manager, Roche