Nouveauté ! Développez votre produit SxMD avec un eQMS structuré comprenant des modèles SxMD prêts à être audités et conformes aux normes EU et US. En savoir plus !
Toutes les fonctionnalités de MatrixALM et MatrixQMS.
Caractéristiques principalesRéglementationTechnologie Stack et caractéristiquesTechnologie Stack et caractéristiquesTemplates Predefined & ConfigurableDocuments & ReportsIntranetIntranetREST API et intégrationsDocuments et supportCaractéristiques principales
Les exigences, les spécifications et les cas d'utilisation peuvent être saisis.
Les tests peuvent être définis, planifiés et exécutés dans plusieurs cycles de test.
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.
La traçabilité entre les éléments peut être définie comme facultative ou obligatoire. Par défaut, plusieurs liens doivent exister entre des exigences, les spécifications et les tests par exemple.
Chaque projet est basé sur un modèle qui définit les éléments de conception qui doivent être gérés, la manière dont la traçabilité est établie et le module de risque qui doit être utilisé.
Tous les éléments du dessin ou modèle sont stockés dans une structure arborescente.
Permet d'utiliser des chaînes de recherche pour trouver des éléments. L'arborescence des éléments peut être filtrée pour n'afficher que les éléments correspondants.
Les fichiers sont stockés à l'aide de clés sécurisées et peuvent être partagés en toute sécurité sans authentification de l'utilisateur.
Toutes les modifications apportées aux éléments sont enregistrées et peuvent être consultées dans l'historique des éléments ou dans le journal des activités de l'ensemble du projet. Les révisions des éléments peuvent être comparées pour voir rapidement ce qui a changé.
Prévisualisez les éléments référencés ou les liens d'éléments dans l'arborescence en plaçant la souris au-dessus et en maintenant la touche Majuscule enfoncée.
Vous pouvez définir des blocs de texte prédéfinis, comme un numéro de version ou l'utilisation prévue, qui peuvent être insérés sous forme de macros dans des champs de texte riche.
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.
Create customized workflows to streamline the onboarding process for various users, including patients, clinicians, and business partners. Choose from multiple options, such as self-registration, clinician-led registration, and point-of-care registration, among other models.
Onboard Patients, Clinicians, and Partners with Tailorable Workflows
Define user roles and assign specific permissions to ensure that only authorized individuals have access to sensitive information. This helps create a secure environment by controlling who can view, edit, or delete certain data and functions.
Define user roles and assign specific permissions
Whether using local user authentication, multi-factor authentication (MFA), token-based authentication, or integration with third-party identity providers (OAuth 2.0), you can configure the system to provide secure and convenient access.
Implement a variety of authentication methods to meet your organization’s security and user experience needs.
Custom schemas ensure that data is organized efficiently and scalably, improving consistency and accessibility.
Design and structure data according to the specific needs of your application or organization.
With filtering, aggregation, and masking options for sensitive data, you can access information efficiently while maintaining security and usability.
Retrieve data in multiple ways to gain tailored insights.
Use charts, graphs, and dashboards to visualize data, enabling easier analysis, data-driven decision-making, and effective communication of insights.
Collect, store, and manipulate data to ensure accuracy and accessibility.
Keep stakeholders informed about important updates and actions without requiring complex configurations.
With a Few Clicks easily configure notifications across multiple communication channels, including email, SMS, voice, and push notifications.
Authentication controls allow only authorized devices to access the system, enhancing security and reducing the risk of unauthorized access.
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.
This plug-and-play approach simplifies the process of adding intelligent functionality for predictive analytics, automation, and other use cases.
Easily integrate AI, machine learning models, or other algorithms into your system.
From logos and colors to custom domain names, ensure that the platform seamlessly reflects your brand and provides a personalized user experience.
Fully customize the platform to align with your brand identity.
The extensibility of the platform ensures it evolves with your needs, offering flexibility and scalability.
Further enhance the platform by creating additional dashboard widgets for visualization or APIs to encapsulate business logic.
Réglementation
Système de gestion de la qualité pour la conception et la fabrication de dispositifs médicaux et exigences à des fins réglementaires. Notre entreprise est certifiée EN ISO 13485:2016, nous connaissons donc bien le sujet !
Supercharge product development & maintain traceability. Get more products out the door & combine existing items from projects for reuse in other projects.
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.
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.
Technologie Stack et caractéristiques
Nous disposons de serveurs aux États-Unis, au Canada, au Royaume-Uni, en Allemagne, en France, en Inde et en Australie. Vous pouvez choisir l'endroit où nous installons votre instance de Matrix Requirements. Nous pouvons également discuter de besoins ou de demandes spécifiques et installer notre application sur Google Cloud, Microsoft Azure, etc.
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.
Technologie Stack et caractéristiques
Nous disposons de serveurs aux États-Unis, au Canada, au Royaume-Uni, en Allemagne, en France, en Inde et en Australie. Vous pouvez choisir l'endroit où nous installons votre instance de Matrix Requirements. Nous pouvons également discuter de besoins ou de demandes spécifiques et installer notre application sur Google Cloud, Microsoft Azure, etc.
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.
Templates Predefined & Configurable
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.
Documents & Reports
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.
With fully managed services, you can focus on your core business while experts handle operational aspects, ensuring smooth performance and minimizing administrative burdens.
Benefit from comprehensive, hands-off system management, including monitoring, maintenance, troubleshooting, and support.
Intranet
Demandez-nous la configuration requise pour le système d'exploitation, la base de données et le serveur web.
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.
Intranet
Demandez-nous la configuration requise pour le système d'exploitation, la base de données et le serveur web.
L'installation et la configuration des sauvegardes sont proposées en tant que service.
Des instructions pour la sauvegarde des bases de données peuvent être fournies.
REST API et intégrations
Nous disposons d'une REST API documentée que nos clients peuvent utiliser pour accéder à notre application. Toutes les fonctions peuvent être réalisées par le biais de REST API .
Les produits de Matrix Requirements peuvent être configurés pour s'intégrer avec :
JIRA Clouds (par le biais d'un module complémentaire gratuit sur la place de marché d'Atlassian)
JIRA Serveur
GitHub
Avec tous ces produits, vous pouvez créer un ticket dans le service externe directement via Matrix, pour notifier à vos collaborateurs qu'ils ont un bug à corriger ou du travail à faire sur les caractéristiques techniques. Le ticket sera lié à l'élément Matrix dans les deux sens, ce qui permettra une parfaite traçabilité entre Matrix et le système de billetterie.
Si vous souhaitez conserver une partie de la source de vérification en dehors de Matrix Requirements, nous pouvons mettre en place la synchronisation (exigences, tests, ...) à partir des services externes suivants :
Confluence (Clouds ou serveur)
Team Foundation Server
GitHub
Zephyr pour JIRA (via ZAPI)
Pivotal Tracker
JIRA (Clouds ou serveur)
La création d'un nouveau convertisseur est assez facile, nous pouvons facilement en créer plusieurs ou vous expliquer comment utiliser notre modèle Java pour en créer un nouveau vous-même.
Documents et support
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.
Consultez notre manuel d'utilisation.
Information security management systems. Our company is also ISO/IEC 27001:2022 certified.
This certification ensures high-quality standards, reducing risks and improving safety and performance.
Developed in compliance with a globally recognized quality management standard, particularly for the healthcare industry.
This is especially important in regulated industries like healthcare, where data protection and compliance are critical.
HITRUST Certification ensures that the system adheres to stringent privacy and security requirements.
Caractéristiques principalesLes exigences, les spécifications et les cas d'utilisation peuvent être saisis.
Les tests peuvent être définis, planifiés et exécutés dans plusieurs cycles de test.
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.
La traçabilité entre les éléments peut être définie comme facultative ou obligatoire. Par défaut, plusieurs liens doivent exister entre des exigences, les spécifications et les tests par exemple.
Chaque projet est basé sur un modèle qui définit les éléments de conception qui doivent être gérés, la manière dont la traçabilité est établie et le module de risque qui doit être utilisé.
Tous les éléments du dessin ou modèle sont stockés dans une structure arborescente.
Permet d'utiliser des chaînes de recherche pour trouver des éléments. L'arborescence des éléments peut être filtrée pour n'afficher que les éléments correspondants.
Les fichiers sont stockés à l'aide de clés sécurisées et peuvent être partagés en toute sécurité sans authentification de l'utilisateur.
Toutes les modifications apportées aux éléments sont enregistrées et peuvent être consultées dans l'historique des éléments ou dans le journal des activités de l'ensemble du projet. Les révisions des éléments peuvent être comparées pour voir rapidement ce qui a changé.
Prévisualisez les éléments référencés ou les liens d'éléments dans l'arborescence en plaçant la souris au-dessus et en maintenant la touche Majuscule enfoncée.
Vous pouvez définir des blocs de texte prédéfinis, comme un numéro de version ou l'utilisation prévue, qui peuvent être insérés sous forme de macros dans des champs de texte riche.
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.
RéglementationSystème de gestion de la qualité pour la conception et la fabrication de dispositifs médicaux et exigences à des fins réglementaires. Notre entreprise est certifiée EN ISO 13485:2016, nous connaissons donc bien le sujet !
Supercharge product development & maintain traceability. Get more products out the door & combine existing items from projects for reuse in other projects.
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.
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.
Technologie Stack et caractéristiquesNous disposons de serveurs aux États-Unis, au Canada, au Royaume-Uni, en Allemagne, en France, en Inde et en Australie. Vous pouvez choisir l'endroit où nous installons votre instance de Matrix Requirements. Nous pouvons également discuter de besoins ou de demandes spécifiques et installer notre application sur Google Cloud, Microsoft Azure, etc.
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.
Technologie Stack et caractéristiquesNous disposons de serveurs aux États-Unis, au Canada, au Royaume-Uni, en Allemagne, en France, en Inde et en Australie. Vous pouvez choisir l'endroit où nous installons votre instance de Matrix Requirements. Nous pouvons également discuter de besoins ou de demandes spécifiques et installer notre application sur Google Cloud, Microsoft Azure, etc.
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.
Templates Predefined & ConfigurableYou 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.
Documents & ReportsAll 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.
IntranetDemandez-nous la configuration requise pour le système d'exploitation, la base de données et le serveur web.
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.
IntranetDemandez-nous la configuration requise pour le système d'exploitation, la base de données et le serveur web.
L'installation et la configuration des sauvegardes sont proposées en tant que service.
Des instructions pour la sauvegarde des bases de données peuvent être fournies.
REST API et intégrationsNous disposons d'une REST API documentée que nos clients peuvent utiliser pour accéder à notre application. Toutes les fonctions peuvent être réalisées par le biais de REST API .
Les produits de Matrix Requirements peuvent être configurés pour s'intégrer avec :
JIRA Clouds (par le biais d'un module complémentaire gratuit sur la place de marché d'Atlassian)
JIRA Serveur
GitHub
Avec tous ces produits, vous pouvez créer un ticket dans le service externe directement via Matrix, pour notifier à vos collaborateurs qu'ils ont un bug à corriger ou du travail à faire sur les caractéristiques techniques. Le ticket sera lié à l'élément Matrix dans les deux sens, ce qui permettra une parfaite traçabilité entre Matrix et le système de billetterie.
Si vous souhaitez conserver une partie de la source de vérification en dehors de Matrix Requirements, nous pouvons mettre en place la synchronisation (exigences, tests, ...) à partir des services externes suivants :
Confluence (Clouds ou serveur)
Team Foundation Server
GitHub
Zephyr pour JIRA (via ZAPI)
Pivotal Tracker
JIRA (Clouds ou serveur)
La création d'un nouveau convertisseur est assez facile, nous pouvons facilement en créer plusieurs ou vous expliquer comment utiliser notre modèle Java pour en créer un nouveau vous-même.
Documents et supportSimplify 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.
Consultez notre manuel d'utilisation.
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.