Alle funktionen von Matrix ALM und Matrix QMS

Dokumentieren von Anforderungen, Spezifikationen und Anwendungsfällen

Individuelle Definiton von Testfällen und Test Exekutierungen, welche in mehreren Testzyklen geplant und ausgeführt werden können.

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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Festlegen von optionaler oder erforderlicher Rückverfolgbarkeit zwischen Items. Standardmäßig müssen verschiedene rückverfolgbare Verbindungen vorgegeben sein, z.B. von Anforderungen zu Spezifikationen und Testfällen.

Anpassbare Projektvorlagen für jedes Projekt, die definieren, wie das Verwalten von Design Items gehandhabt, wie die Rückverfolgbarkeit strukturiert und wie das Risk Modul genutzt werden soll.

Anlage aller Design Items in einer Baumstruktur.

Möglichkeit der Verwendung von Suchzeichenfolgen, um Items zu finden. Der Elementbaum kann gefiltert werden, um nur übereinstimmende Items anzuzeigen.

Das Speichern von Dateienanhängen erfolgt unter Nutzung von Sicherheitsschlüsseln, damit diese sicher geteilt werden können, auch ohne Nutzerauthentifizierung

Abspeichern von allen Item-Änderungen und Nachverfolgbarkeit dieser in der Historie der Items oder auf Projektebene. Revisionen der Items können nebeneinander gestellt werden, um Änderungen schnell erfassen und vergleichen zu können.

Möglichkeit der Vorschau von verlinkten Items oder der Elementverknüpfungen im Baum, durch das Gedrückthalten der Umschalttaste während Sie mit der Maus darüber hovern

Erstellen von vordefinierten Textblöcken, wie die Versionsnummerierung oder die vorgesehene Nutzung, die dann als Makros in Volltextboxen eingefügt werden können.

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.

Onboard Patients, Clinicians, and Partners with Tailorable Workflows

Define user roles and assign specific permissions

Implement a variety of authentication methods to meet your organization’s security and user experience needs.

Design and structure data according to the specific needs of your application or organization.

Retrieve data in multiple ways to gain tailored insights.

Collect, store, and manipulate data to ensure accuracy and accessibility.

With a Few Clicks easily configure notifications across multiple communication channels, including email, SMS, voice, and push notifications.

Monitor and manage connected devices to ensure they are running the correct firmware versions and functioning properly.

Seamlessly connect and exchange data with external systems such as Electronic Medical Records (EMR), Laboratory Information Systems (LIS), and Laboratory Information Management Systems (LIMS). This ensures smooth interoperability and eliminates data silos.

Easily integrate AI, machine learning models, or other algorithms into your system.

Fully customize the platform to align with your brand identity.

Further enhance the platform by creating additional dashboard widgets for visualization or APIs to encapsulate business logic.

Quality management system for the design and manufacture of medical devices and requirements for regulatory purposes. Wir sind EN ISO 13485:2016 zertifiziert, daher sprechen wir aus Erfahrung!

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.

Wir verfügen über Server in den USA, in Kanada, im Vereinigten Königreich, in Deutschland, Frankreich, Indien und Australien. Sie können dabei auswählen, wo wir Ihre Matrix Requirements Instanz installieren. Alternativ können wir auch spezielle Anforderungen oder Wünsche beachten und unsere Anwendung auch auf Google Cloud, Microsoft Azure usw. installieren.

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.

Wir verfügen über Server in den USA, in Kanada, im Vereinigten Königreich, in Deutschland, Frankreich, Indien und Australien. Sie können dabei auswählen, wo wir Ihre Matrix Requirements Instanz installieren. Alternativ können wir auch spezielle Anforderungen oder Wünsche beachten und unsere Anwendung auch auf Google Cloud, Microsoft Azure usw. installieren.

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.

Benefit from comprehensive, hands-off system management, including monitoring, maintenance, troubleshooting, and support.

Wir helfen gerne bei Fragen bezüglich der Voraussetzungen und Anforderungen für OS, Datenbanken und Webserver.

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.

Wir helfen gerne bei Fragen bezüglich der Voraussetzungen und Anforderungen für OS, Datenbanken und Webserver.

Wir bieten Services zur Installation und Erstellen einer Sicherheitskopie der Konfiguration.

Wir stellen Instruktionen zur Datenbanksicherung zur Verfüung.

Wir stellen unseren Kunden eine dokumentierte REST API zur Verfügung, die genutzt werden kann, um alle Funktionen unserer Software durch die REST API anzusprechen.

Unsere Matrix Requirements Produkte können konfiguriert werden, um mit den folgenden Applikationen zu integrieren:

• JIRA Clouds (durch ein kostenfreies Add-on im Atlassian Marketplace)

• JIRA Server

• GitHub

In den gelisteten externen Services können direkt in der Matrix Nutzeroberfläche Tickets erstellt werden, um Kollegen zu Informieren, dass ein Fehler behoben oder an Spezifikation gerarbeitet werden soll. Die Tickets sind in beide Richtungen verlinkt, was eine hervorragende Rückverfolgbarkeit zwischen Matrix und dem Ticketing System ermöglicht.

Falls Teile der Wissensquellen außerhalb von Matrix Requirements aufbewahrt werden sollen, können Synchronisationen (von Requirements, Tests, usw...) mit den folgenden externen Applikationen eingerichtet werden:

• Confluence (Clouds oder Server)

• Team Foundation Server

• GitHub

• Zephyr for JIRA (via ZAPI)

• Pivotal Tracker

• JIRA (Clouds oder Server)

Einen neuen Konverter einzurichten ist recht einfach, daher können wir hier auch individuelle Wünsche beachten oder dabei behilflich sein, wie das Java template zu nutzen ist, um selbst einen solchen Konverter einzurichten.

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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Unser Benutzerhandbuch befindet sich hier

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

Developed in compliance with a globally recognized quality management standard, particularly for the healthcare industry.

HITRUST Certification ensures that the system adheres to stringent privacy and security requirements.