Matrix Req

Matrix Req

Matrix One
aligned elements

aligned elements

Aligned AG
+
+

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About

Matrix Req (formerly Matrix Requirements) is a collaborative, AI-powered software explicitly built to meet the rigorous needs of medical device development. It helps cross-functional teams design, build, and launch high-quality medical devices while maintaining complete, end-to-end traceability of requirements, risks, and tests. The platform automates the cumbersome audit preparation process by generating structured documentation and trace matrices directly from live data, reducing regulatory submission timelines from weeks to days. Trusted by over 500+ life sciences companies, Matrix Req ensures that compliance is built-by-design rather than treated as an afterthought.

About

Aligned eQMS and Aligned Elements Design Control software are built specifically for medical device and IVD companies that need to meet global regulatory requirements without unnecessary complexity. The platform supports compliance with ISO 13485, FDA QSMR, EU MDR, and IVDR, and is trusted by experts that want full control over quality, design, and regulatory processes across the entire product lifecycle. Aligned products, designed for collaboration between quality, regulatory, R&D, and management teams, combines a complete electronic Quality Management System with deep Design Control functionality in one fully integrated environment. Design inputs, outputs, verification, validation, risk management, and change control are natively connected to the QMS, ensuring end to end traceability that stands up to audits and inspections.

Platforms Supported

Windows Supported
Mac Supported
Linux Supported
Cloud Supported
On-Premises Supported
iPhone Not Supported
iPad Not Supported
Android Not Supported
Chromebook Supported

Platforms Supported

Windows Supported
Mac Not Supported
Linux Not Supported
Cloud Supported
On-Premises Supported
iPhone Not Supported
iPad Not Supported
Android Not Supported
Chromebook Not Supported

Audience

Medical device companies

Audience

Medical Device Manufacturers looking for a design control management solution

Support

Phone Support Supported
24/7 Live Support Supported
Online Supported

Support

Phone Support Supported
24/7 Live Support Not Supported
Online Supported

API

Offers API Supported

API

Offers API Supported

Screenshots and Videos

Screenshots and Videos

Pricing

$500 per month
Free Version Supported
Free Trial Supported

Pricing

€1300 per year
See: 'How to buy' on our homepage for the full offer
Free Version Not Supported
Free Trial Supported

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

Review this Software

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

Review this Software

Training

Documentation Supported
Webinars Supported
Live Online Supported
In Person Supported

Training

Documentation Supported
Webinars Not Supported
Live Online Supported
In Person Supported

Company Information

Matrix One
Founded: 2016
United States, Germany, France, Belgium, United Kingdom
matrixone.health/products/matrix-req

Company Information

Aligned AG
Founded: 2007
Switzerland
www.aligned.ch/

Alternatives

Alternatives

ReqView

ReqView

Eccam
aligned elements

aligned elements

Aligned AG
Matrix Quality

Matrix Quality

Matrix One
Kovair ALM-PLM CoE

Kovair ALM-PLM CoE

Kovair Software
Kovair ALM

Kovair ALM

Kovair Software

Categories

Categories

Requirements Management Features

Automated Functional Sizing Not Supported
Automated Requirements QA Not Supported
Automated Test Generation Not Supported
Automated Use Case Modeling Not Supported
Change Management Supported
Collaboration Supported
History Tracking Supported
Prioritization Supported
Reporting Supported
Status Reporting Supported
Status Tracking Supported
Summary Reports Supported
Task Management Supported
To-Do List Not Supported
Traceability Supported
User Defined Attributes Supported

Requirements Management Features

Automated Functional Sizing Not Supported
Automated Requirements QA Supported
Automated Test Generation Supported
Automated Use Case Modeling Not Supported
Change Management Supported
Collaboration Supported
History Tracking Supported
Prioritization Supported
Reporting Supported
Status Reporting Supported
Status Tracking Supported
Summary Reports Supported
Task Management Supported
To-Do List Supported
Traceability Supported
User Defined Attributes Supported

Application Lifecycle Management Features

Administrator Level Control Supported
Defect Tracking Supported
Iteration Planning Not Supported
Project Management Not Supported
Release Management Supported
Requirements Review Supported
Task Management Supported
Test Case Tracking Supported
User Level Management Supported
Version Control Supported

Integrations

GitHub Supported
GitLab Supported
Apache Subversion Not Supported
Azure DevOps Supported
Azure DevOps Server Not Supported
Confluence Supported
Jira Supported
Jira Align Not Supported
Matrix Quality Supported
Redmine Not Supported

Integrations

GitHub Supported
GitLab Supported
Apache Subversion Supported
Azure DevOps Not Supported
Azure DevOps Server Supported
Confluence Not Supported
Jira Not Supported
Jira Align Supported
Matrix Quality Not Supported
Redmine Supported
Claim Matrix Req and update features and information
Claim Matrix Req and update features and information
Claim aligned elements and update features and information
Claim aligned elements and update features and information