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Platform
Product
ALMALM
QMSQMS
Persona
DeveloperR&D
RAQARAQA
CTOCTO
Use case
TimeReducing Time on Paperwork
StarRequirement & Risk Management
Pencil and rulerTraceability In Design
StethoscopeSxMD (SaMD, SiMD)
TodoPreparing Regulatory Submissions
ComplianceBecoming Compliant
CycleManaging Product Development
LaptopDigital Quality Management
StartupsMedtech Startup
Pricing
Resources
Inspiration
Customer success storiesCustomer success stories
BlogBlog
CommunityCommunity
Learn
KnowledgebaseKnowledge Base
GuidesGuides
Events and webinarsEvents & webinars
Tools
Key featuresKey features
Product FAQProduct FAQ
Explainer videosExplainer videos
Developers
Company
Learn more
About usAbout us
CareersCareers
Contact usContact us
Free trialDemo

All MatrixALM and MatrixQMS features.

Core featuresCore Features
RegulatoryRegulatory
Technology stackTechnology Stack & Specifications
IntranetIntranet Version
ConfigurationConfiguration Options
REST APIREST API and Integrations
DocumentationDocumentation and Support
Core featuresCore Features
Fully integrated risk 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, 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.
Full Text Search
Allows you to use search strings to find items. The item tree can be filtered to show only matching items.
Live Traceability Verification
The user interface will indicate if the traceability is broken, missing or outdated.
File Attachments
Files are stored using secure keys, and shareable securely without user authentication.
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
Preview referenced items or the item links in the tree by hovering the mouse over them with shift pressed.
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 documents or emails allowing other with access to the project to directly access the item.
Project Analysis Reports
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.
Controlled Documents
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.
Document Templates
You can setup document templates, and share them for use 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 and are automatically linked 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
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.
RegulatoryRegulatory
FDA 21 CFR part 11
Full support for compliance with FDA 21 CFR part 11 for electronic records including electronic signatures. Ask us for a gap analysis.
ISO 13485

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!

FDA CFR part 820
Quality System Regulations.
IEC 62304
Medical device software – software life cycle process.
IEC 82304
Health software -- Part 1: General requirements for product safety.
IEC 62366
Application of usability engineering to medical device.
ISO 14971
Application of a risk management system for medical devices.
ISO 27001

Information security management systems. Our company is also ISO/IEC 27001:2013 certified.

Technology stackTechnology Stack & Specifications
Data Centers
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.
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
Define user rules per project.
Passwords
Password aging and required password strength can be configured.
XML Export
All project data including audit trail can be exported as xml.
Excel Support
Database items can be exported as xlsx files.
Reporting and Documents

Reports and documents can be creates as html, word, pdf or excel for custom tables

IntranetIntranet Version
System Requirements

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

Installation Services
Installation and backup configuration offered as service.
Backups
Instructions for backing up databases can be provided.
ConfigurationConfiguration Options
Item Categories
MatrixALM can be easily configured to describe any Design Input and Design Output categories.
Item Structure
Each item category can have different fields and hold values. Like, rich text, dropdown, tables, etc...
Document and Reports

Custom document and report can be created to export your data the way you need it

Word Templates
Can be customized.
Controlled Documents
Define default templates for new controlled documents.
Risk Module
Configurable for different risk assessment methodologies and risk levels.
Test Module
Configurable to offer different test results for individual test steps and rules how to compute the overall result from the test step results.
Traceability Rules
Required traces between items are configurable.
Variants/Labels
Labels can be set for each category.
REST APIREST API and Integrations
REST API

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

Buit-in Integrations

Matrix Requirements products 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.

DocumentationDocumentation and Support
User Manual

Our User Manual is here.

Administration Guide

Administration and configuration is explained here.

Support

Fast, quality support whenever you need it. Reach us through our JIRA service desk portal here.