Requirements ManagementRequirements, 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 ModuleTest cases can be defined and tests can be planned and executed in multiple test cycles.
TraceabilityTraceability 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 TemplatesEach 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 StructureAll design items are stored in a tree structure which allows to organized them in way to easily find them.
Full Text SearchAllows you to find any item based on search strings. The item tree can be filtered to show only matching items.
Live Traceability VerificationIf the traceability is broken or suspicious, i.e. a trace is missing or outdated the user interface will directly indicate this.
File AttachmentsCan 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 HistoryAll 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 PreviewReferenced 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 ReportAll changes done in a given period can be shown.
Session CommentsSeveral changes to the project can be logged under the same change comment without re-entering it for every change.
Unique Item LinksEach 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 ReportsReports 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 DocumentsDocuments 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 TemplatesYou can setup document templates, release them and use them in other projects.
Document ArchiveUnlimited documents can be archived.
Electronic SignaturesArchived documents can be signed electronically.
Stale Object WarningsIf a user works on an item which has been modified by someone else, it will be indicated in the user interface.
Item Review WorkflowYou 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 FormattingProjects 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-inIssues 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 BlocksYou 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 ReferencesAll to reference any item in other projects.
Project TemplatesYou can create reusable project templates to get you started quickly if you have multiple similar projects.
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.
Quality management system for the design and manufacture of medical devices.
Our company is ISO13485:2016 certified
so we do know what this is all about!
FDA CFR part 820:
Quality System Regulations
Medical device software – software life cycle process
Application of usability engineering to medical device
application of a risk management system for medical devices
Technology Stack & Specification
We have servers in the US, 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.
Debian Linux 9 (Stretch) is our default OS.
PostgreSql 9.6 - Secure database storing all data. Each customer has its own private database.
Tomcat 8 and nginx
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
User roles per project - Access Control Lists to define who can change which field in which project.
Password ageing and required password strength can be configured
All project data including audit trail can be exported as xml
Database items can be exported as xlsx files
Reporting and Documents
Reports and documents (html, word and pdf) are created using xslt 2. Custom xslt can be provided for document generation.
Requires Debian Linux 8+ Installation with Tomcat 8+, PostgreSql 9.2+.
Alternatively, can be installed on Windows or OS/X
Installation and backup configuration offered as service
Instructions for backing up databases can be provided
By default, there are Requirements, Use Cases, Specifications, Risks, Test Cases and Runs as categories. It is possible to add or remove categories.
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
Custom or modified reports can be added. Reports are simple xslt transformation of the project’s data.
can be customized.
It is possible to define default templates for new controlled documents.
The risk module can be configured to use different risk assessment methodologies and risk levels within.
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.
It can be configured which traces between items can or must exist.
It is possible to define which labels can be set for each category
REST API and integrations
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.
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
- Zephyr for JIRA
- 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
Our User Manual is here
Administration and configuration is explained here
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):