MatrixQMS and MatrixALM Products | Matrix Requirements
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Application Lifecycle Management

Simple and Efficient Requirements Management
  • Capture all design inputs and outputs
  • Integrated risk management
  • Integrated verification and validation
  • Electronic signatures
More details


Quality Management System

Lean and Agile
Quality Management
  • Write, review and publish processes quickly
  • Integrated risk management
    (as requested by ISO13485:2016)
  • Integrated gap analysis
  • Integrated CAPAs
More details


Application Lifecycle Management for medical devices

Our ALM solution helps your team build medical devices with less stress.

Instead of writing big Word documents and trying to maintain Excel files for traceability and risks, MatrixALM allows you to update user and system requirements. Also technical specifications, tests, test results, risks and everything else you need to document for your design, can be created in an agile way.

Let your whole team participate and benefit from up-to-date documentation!



MatrixALM allows you to define any number of layers of requirements, which define the design input and output.
It helps in verifying that the traceability is correct and complete within the whole design development.

requirement management

Risk Management

The Risk Module allows you to design forms to enter the risks you need to document according to ISO14971. You can customize the forms and formulas according to your procedures and hazard analysis.
Risk controls directly act as design input.

risk management

Verification and Validation

Verification and validation tests can be defined for any layer of requirements. Test scripts can include other tests and run external tools to collect automated test results.
If a test step fails it can be linked to any external ticketing system like JIRA.

Verification and validation


From the database stored design input and output you can create documents which render the data as you need it. It can dynamically include anything from simple requirements to complex trace tables.
Documents can be electronically signed whenever you reach a milestone with your medical device.

technical file generation


No two medical device projects are the same, so we make it easy to add layers, input fields and traceability rules. See the list of features for more details.

project configuration


Look at our video introducing MatrixALM


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Quality Management System for medical devices

Our QMS solution helps your team build a great quality system.

MatrixQMS helps you to bridge the gap between the engineering teams and the quality department. It allows your RA/QA consultants to focus on the important things!



MatrixQMS allows you to add your own specific standards besides ISO13485, ISO27001 and others, which come with the system.
These make it easier to develop your processes and create a gap analysis against the regulatory standards for medical devices.

included standards


In this section you define all required processes directly linked to the requirements in the standards. Keep them small and simple so that you and the auditor can understand them.
If you are just starting to build your quality system you can kickstart it with our library of typically required processes.

Defining procedures linked to standards


When you use ISO 13485:2016 you now need to do a risk analysis for your processes.
This is easy, fast and efficiently achieved with the integrated Risk Module.

Defining risks linked to procedures

Work Instructions

Work Instructions is the place where are all your technical details for a process are recorded.
These can be updated quickly to keep everything and everyone working effectively.

Work instructions linked to procedures


An integrated CAPA project allows you to log corrective and preventive actions and link them to the tasks in your issue tracking software.

Management of CAPAs

Traceability and Audit Log

Matrix will take care of the traceability in your QMS and automatically build an audit log with each change for quality control.
A rigorous review process is integrated in MatrixQMS, to ensure no procedure or work instruction is published unless it's been approved.

traceability standards, procedures, risks, work instructions

Published QMS

When all the processes are approved, the QMS can be published to the team to make it easily accessible for everyone.
The published view is streamlined to allow anyone in the company to find the procedures and work instructions that (s)he needs to use.

QMS publication


Look at our video introducing MatrixQMS


Try for Free

Get your own QMS playground



Let us demonstrate our QMS to you



Contact us by mail, chat or phone


Videos and Webinars

  • 01

    MatrixALM Introduction

    This video shows the basic principle of MatrixALM and how you can efficiently manage the Development of your Medical Device and its related documentation (DHF).
  • 02

    MatrixQMS Introduction

    This video shows the basic principle of MatrixQMS and how you can efficiently manage the Quality Management System of your Medical Device.
  • 03

    Requirements Management

    This webinar introduces MatrixALM: how to document your design input and output, managing traceability and revisions.
  • 04

    Risk Management

    This webinar explains how risks can be documented and linked to mitigations. It also covers how to document the risk analysis and FMEA tables. Finally it shows how the risk module can be configured to adopt it to your methodology.
  • 05

    Test Management

    This webinar explains how to manage the validation and verification of your Medical Device. It explains how to define test cases and how they can be run in multiple test cycles. It also shows how to keep track of the testing progress, using the test management dashboards, and how to document the result.
  • 06

    JIRA linkage configuration

    This webinar shows the advantages of linking JIRA to Matrix Requirements and how to configure it correctly.

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