All MatrixALM and MatrixQMS features.

Requirements, specifications and use cases can be captured. Risks can be defined according to customizable templates and formulas. Risk mitigations can be defined. Configurable for different risk assessment methodologies and risk levels.

Test cases can be defined and tests can be planned and executed in multiple test cycles.

Develop software as/in a Medical Device (SxMD) with an off-the-shelf structured eQMS using audit-ready templates aligned with EU and US standards that ensure compliance.

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The user interface will indicate if the traceability is broken, missing or outdated.

MatrixALM can be easily configured to describe any Design Input and Design Output categories.

Each item category can have different fields and hold values. Like, rich text, dropdown, tables, etc...

Each design item, report, or controlled document has a unique link, like a website. This link can be embedded in other documents or emails allowing others with access to the project to directly access the item.

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

Several changes to the project can be logged under the same change comment without re-entering it for every change.

Sign documents electronically. Full support for compliance with FDA 21 CFR part 11 for electronic records including electronic signatures.

If a user works on an item which has been modified by someone else, it will be indicated in the user interface.

Projects have a central time zone and date time formatting which is used by all team members and reports. The user interface of each team member can be adjusted to their location and date time formatting preferences.

Issues related to any item can be tracked in Jira clouds. Issues found during testing can be added and are automatically linked to the executed test cases.

You can define pre‐defined text blocks like a version number or the intended use, which can be inserted as macros in rich text fields.

Reference any item in other projects.

All project data including audit trail can be exported as xml.

Database items can be exported as xlsx files.

Complete validation documentation, ISO 13485 and ISO 27001 certification, and a pre-populated project that you can use to validate your configuration (e.g. the risk analysis formulas). The same project can also be used to efficiently validate other tools that require validation.

Quickly perform and document design and quality process reviews.

Supercharge product development & maintain traceability. Get more products out the door & combine existing items from projects for reuse in other projects.

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Develop, test, and deploy faster. Increase productivity by enabling teams to work on multiple product releases in parallel, fix bugs, and work on prototype ideas without affecting the main codebase.

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Labels can be set for each category. It is possible to define labels which can be attached to items of a given item category. For example test cases could be marked as smoke or regression tests or both, or requirements as being important for FDA, CE or both. The tree and reports can be filtered by these labels.

This module helps you administer big groups of users, in order to more easily assign access rights to projects.

Multiple single sign-on provider options.

If you wish to keep some of the source of truth outside of Matrix Requirements, we can set up the synchronization (requirements, tests, ...) from the following external services:

• Confluence (Clouds or server)

• Team Foundation Server

• GitHub

• Pivotal Tracker

• JIRA (Clouds or server)

Creating a new converter is quite easy, we can easily do others or explain you how to use our Java template to create a new one yourself.

AI based translation of individual fields into another language.

Copy and paste content from field(s) in an item to other items.

The Print Table Sorter enables you to select the parameters you want to sort the table by so that you can quickly present data in a meaningful way.

A detailed view of project traceability at the category level for up traces and down traces.

See user access and group access for all users and groups regardless of your user type in this dashboard.

Copy a selection of item(s) to one or more folders simultaneously.

Copy one field into multiple items in a project.

Automatically remove empty tables in your printed documents.

Check traces with this interactive trace dashboard that visualizes the interrelation of your traces.

Create hot links to common sites your team needs to access directly in the help menu.

Show or hide a field or hide one field and show another at the category level with a checkbox status.

Risk dashboards to see detailed information for your risk matrix and RBM and RAM stats.

Automatically add “dirty” labels in down-traces when an item is modified.

Import Microsoft Excel data while keeping traces and external links.

Create review packets for different review types per category to make requesting reviews as easy as two clicks directly from the item.

Manage and link Complaints with Non-Conformities and CAPAs. Needs Variants/Labels module.

Manage your critical and non-critical supplier criteria to prove your supplier diligence for the ALM essential package.

Clean and simple QMS structure without template procedures or risks. Needs Variants/Labels module, Needs Reviews module.

Manage and monitor the calibration of equipment and tools. Needs Variants/Labels module.

A sample project with a software V-model for software development with SOUP category.

A publishable QMS structure with macro process layers and a global training layer. Needs Variants/Labels module, Needs Reviews module.

A sample project with a simple V-model for software development with two layers of design input and output.

An HR project to manage roles, job description and training.

Structure of different standards, regulations, and guidelines that are publicly available.

An example project structure for a combined product using both hardware and software. Needs Variants/Labels module, Needs Reviews module.

Manage your critical and non critical supplier criteria to prove your supplier diligence. Needs Variants/Labels module.

Consolidate Audit categories with their related CAPAs. Needs Variants/Labels module.

Manage change controls with approval workflows. Needs Variants/Labels module.

Collect and manage complaints compliantly. Needs Variants/Labels module.

Manage and monitor calibration and preventive maintenance of equipment. Needs Variants/Labels module.

You can setup document templates, and share them for use in other projects.

You can create reusable project templates to get you started quickly if you have multiple similar projects. Each project is based on a template which defines the design items that should be managed, how the traceability is set up and which risk module should be used.

Predefined templates with traceability mapped out to standards to get started. Adapt them according to your own company details.

Generate and publish a digital Quality Manual of your company’s internal procedures and all related training procedures.

Store roles, staff, and training records in a dedicated database.

Can be customized.

Define default templates for new controlled documents.

Audit-ready flexible templates that dynamically pull data from Matrix into the templates with full traceability to all the standards that govern them.

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All changes done in a given period can be shown. Reports and documents can be creates as html, word, pdf or excel for custom tables

Analyze the content and traceability of projects, perform test planning and execution, design reviews, risk assessment etc. Reports have links directly into the project for quick access to issues. Reports and documents can be created as html, word, pdf, or excel for custom tables.

Custom reports can be created to export your data the way you need it. Reports and documents can be created as HTML, word, pdf or excel for custom tables

Custom documents can be created to export your data the way you need it. Reports and documents can be creates as html, word, pdf or excel for custom tables

Documents can be built like building blocks and are connected to the project. Sections can be automatically populated with the latest project data. Each controlled document can be frozen at any time. Define default templates for new controlled documents. Reports and documents can be created as HTML, word, pdf or excel for custom tables

Unlimited documents can be archived.

We have servers in the US, in Canada, UK, Germany, France, India, and Australia. You can choose where we install your Matrix Requirements instance. Alternatively, we can discuss special needs or requests, and we can install our application also on Google Cloud, Microsoft Azure, etc.

HTML 5 Client (compatible with latest Chrome, Safari, Firefox, Edge at time of release). Chrome recommended for best user experience.

Multi user access through a web application with a secure access protocol. Check our certificates here.

Define user rules per project.

Password aging and required password strength can be configured.

Ask us for the current requirements for the OS, database, and web server.

We have a documented REST API that our customers can use to access our application all functions can be achieved through the REST API.

Matrix Requirements products can be configured to integrate with:

• JIRA Clouds (through a free add-on on the Atlassian Marketplace)

• JIRA Server

• GitHub

With all these, you can create a ticket in the external service directly through Matrix, to notify your coworkers they have a bug to fix or some work to do on specifications. The ticket will be linked both ways to the Matrix item, allowing for a great traceability between Matrix and the ticketing system.

If you wish to keep some of the source of truth outside of Matrix Requirements, we can set up the synchronization (requirements, tests, ...) from the following external services:

• Confluence (Clouds or server)

• Team Foundation Server

• GitHub

• Zephyr for JIRA (through ZAPI)

• Pivotal Tracker

• JIRA (Clouds or server)

Creating a new converter is quite easy, we can easily do others or explain you how to use our Java template to create a new one yourself.

Simplify your path to ISO 13485 certifications with our tailored internal audits. Whether online or onsite, our certified auditors leverage in-depth Matrix expertise to efficiently enhance your Quality Management System.

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Quality management system for the design and manufacture of medical devices and requirements for regulatory purposes. Our company is EN ISO 13485:2016 certified so we do know what this is all about!

Information security management systems. Our company is also ISO/IEC 27001:2022 certified.