Technical Information

Features

Requirements Management

Requirements, specifications and use cases can be captured.

Risk Module

Risks can be defined according to customizable templates and formulas. Risk mitigations can be defined.

Test Module

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

Traceability

Traceability between items can be set up as optional or required. By default, several traces must exist, e.g. from requirements to specifications and test cases.

Predefined or Customizable Project Templates

Each project is based on a template which defines the design items that should be managed with Matrix Requirements Medical, how the traceability is set up and which risk module should be used.

Hierarchical Data Structure

All design items are stored in a tree structure which allows to organized them in way to easily find them.

Full Text Search

Allows you to find any item based on search strings. The item tree can be filtered to show only matching items.

Live Traceability Verification

If the traceability is broken or suspicious, i.e. a trace is missing or outdated the user interface will directly indicate this.

File Attachments

Can be made in any text control or special file attachment sections. all categories possible. Files are stored using secure keys, allows to share the files securely without user authentication (like sharing a dropbox file)

Full Item History

All changes to items are logged and can be seen in the items history or the project wide activity log. Revisions of items can be compared to see quickly what changed.

Item Preview

Referenced items can be previewed without leaving the current item by hovering the mouse with shift pressed over the referenced item or the item links in the tree.

Change Summary Report

All changes done in a given period can be shown.

Session Comments

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

Unique Item Links

Each design item, report or controlled document has a unique link, like a web-site. This link can be embedded in other document or email allowing other to directly access the item. (if they are granted access to the project).

Project Analysis Reports

Reports can be used to analyze the content and traceability of projects, to perform test planning and execution, design reviews, risk assessment etc. Reports have links directly into the project allowing to quickly fixing issues.

Controlled Documents

Documents can be built of building blocks, like audit trails, signatures boxes etc. They are connected to the project and can have sections which are automatically populated with the latest project data. Each controlled document can be frozen at any time.

Document Templates

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

Document Archive

Unlimited documents can be archived.

Electronic Signatures

Archived documents can be signed electronically.

Stale Object Warnings

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

Item Review Workflow

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

Variants (Labels and Filters)

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.

Time Zone and Formatting

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.

JIRA Clouds Plug-in

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

Smart Text Blocks

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

Cross Project References

All to reference any item in other projects.

Project Templates

You can create reusable project templates to get you started quickly if you have multiple similar projects.

Regulatory

FDA 21 CRF part 11: Electronic Records, Electronic Signatures

Full support for compliance with FDA 21 CRF part 11 including electronic signatures. Ask us for a gap analysis.

ISO 13485:

Quality management system for the design and manufacture of medical devices

FDA CFR part 820:

Quality System Regulations

IEC 62304:

medical device software – software life cycle process

IEC 62366:

Application of usability engineering to medical device

ISO 14971:

application of a risk management system for medical devices

Technology Stack & Specification

Data Centers

We have servers in Canada, Germany, France 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.

OS

Debian Linux 9 (Stretch) is our default OS.

SQL Database

PostgreSql 9.6 - Secure database storing all data. Each customer has its own private database.

Webserver

Tomcat 8 and nginx

Frontend

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

HTTPS

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

Access control

User roles per project

Passwords

Password ageing and required password strength can be configured

XML export

All project data including audit trail can be exported as xml

Excel export

Database items can be exported as xlsx files

Reporting and Documents

Reports and documents are created using xslt 2. Custom xslt can be provided for document generation.

Intranet Version

System Requirements

Requires Debian Linux 8+ Installation with Tomcat 8+, PostgreSql 9.2+.
Alternatively, can be installed on Windows or OS/X

Installation Services

Installation and backup configuration offered as service

Backups

Instructions for backing up databases can be provided

Configuration Options

Configuration Options

Item Categories

By default, there are Requirements, Use Cases, Specifications, Risks, Test Cases and Runs as categories. It is possible to add or remove categories.

Item Structure

Each item consists of several input fields and controls e.g. a rich text editor or a table control. This structure can be modified by adding or removing controls (see a list of available controls).

Reports

Custom or modified reports can be added. Reports are simple xslt transformation of the project’s data.

Word Templates

can be customized.

Controlled Documents

It is possible to define default templates for new controlled documents.

Risk Module

The risk module can be configured to use different risk assessment methodologies and risk levels within.

Test Module

can be configured to offer different test results for individual test steps and rules how to compute the overall result from the test step results.

Traceability Rules

It can be configured which traces between items can or must exist.

Variants/Labels

It is possible to define which labels can be set for each category

REST API and integrations

REST API

We can provide our customers with a description of our REST API. Our front-end application only uses that API, so all functions can be achieved through the REST API.

Built-in integrations

Matrix Requirements Medical can be configured to integrate with: 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.

Agile Sync clients

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.

Documentation and Support

User Manual

Our User Manual is here

Administration Guide

Administration and configuration is explained here

Support

We are very proud to provide one of the fastest support on the planet. Reach us through our JIRA service desk portal here.
Here is our satisfaction report over the last year (stars / 5):
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