QMS

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
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ALM

Application Lifecycle Management

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

QMS

Quality Management System

The MatrixQMS solution helps your team building a quality system which is alive and kicking.
Instead of big procedures written by others for others (which make your work harder), MatrixQMS allows you to optimize your key processes quickly and efficiently.
Don't be afraid to change procedures anymore!

1

Standards

This section allows you to add your own specific standards besides ISO13485, ISO27001 and others which come with the system to make it easy to develop your processes and create a gap analysis against the standards.

2

Procedures

In this section you define all required processes directly linked to the sections 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.

3

Risks

Using ISO 13485:2016 you need to do a risk analysis for your processes. This is easy, fast and efficient with the integrated risk module.

4

Work Instructions

Work instructions are all your technical details for a process. These need to be understandable by the domain experts.

5

CAPAs

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

6

Traceability and Audit Log

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

7

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 finding the procedures and work instructions that (s)he needs to deal with.

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ALM

Application Lifecycle Management

The MatrixALM solution helps your team building products with less documentation stress. Instead of writing big word documents and trying to maintain excels for the traceability and risks, Matrix allows to update user and system requirements, technical specifications, tests, test results, risks and every else you need to document for your design, in an agile way. Let your whole team participate and benefit from always up-to-date documentation!

1

Requirements

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

2

Risk Management

The risk module allows you to define 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. The risk controls are managed in the same screen, and the final Risk After Mitigation computation is immediate.

3

Verification and Validation

Verification and validation tests can be defined for any layer of requirements. Tests scripts can include other tests and run external tools to collect automated test results. Tests executions are traced to the tests, allowing you to see in which version the tests failed, if there was an external ticket (JIRA or other applications) generated, ...

4

Documentation

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

5

Configuration

No two medical device projects are the same, so we make it easy to add layers, input fields and traceability rules.

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Videos

  • 01

    MatrixQMS

    This video shows the basic principle of MatrixQMS.
  • 02

    Requirements and Risk Management

    This video shows how items can be organized in a tree structure and links to these items can be embedded into documents or email. You can see how requirements are created and linked to specifications. It shows how risks can be defined and linked to mitigations. It also covers some design and risk analysis reports.
  • 03

    Traceability

    This video shows how design input and output is connected and how you can navigate in the project. You can learn how the software indicates when traces or items are missing or are out of date and how to inform your team. It also shows examples of reports that help you to verify and document the traceability.
  • 04

    Reports

    Learn how to select which items to include in reports and choose whether to create it as HTML, Word or PDF. See some examples of the default reports that can be generated: to document the design, create test instructions and document test results. Perform a risk analysis and traceability analysis report and finally learn how to prepare and record design reviews.
  • 05

    Access Control and Versions

    This video shows how every change creates a new version of the item. It shows how to look at and restore previous versions of the same item and where the revision number of a version shows up in reports. It explains the concept of session comments which allow you to use the same comment for multiple changes rather than entering a new comment for every single change.
  • 06

    Testing

    This video explains how to define test cases and how they can be run in multiple test cycles. Learn how to enter the test results directly into the software and how to create reports with the test results. It also shows the reports you can create to print test instructions and to verify that the test cases cover all requirements and risks.

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