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 !
Conformité règlementaire SxMD avec MatrixALM
Contrôlez la conception des dispositifs médicaux grâce à une solution agile tout-en-un pour SaMD. Gérez facilement les documents techniques, les tests et les risques pour pour bien préparer votre audit.
Accélérer la mise sur le marché
Plateforme logicielle flexible et facile à utiliser, conçue pour combler le fossé entre l’agilité et la conformité.
Créez des dispositifs médicaux avec une traçabilité complète des données de conception.
Recueillez, documentez et gérez toutes les exigences sur plusieurs niveaux.
Vérification de la traçabilité en temps réel.
Élaborez une documentation des risques sur mesure, basée sur des procédures entièrement personnalisables pour répondre à tous les besoins en matière de dispositifs médicaux.
Gérez et reliez les menaces de cybersécurité aux risques de sécurité
Intégrez de manière transparente le contrôle des risques dans les données de conception.
Vérifiez les exigences et les tests à plusieurs niveaux de validation tout au long du processus de conception.
Accélérez l'exécution des tests et gérez les séquences de tests à grande échelle.
Intégrez les outils de développement pour automatiser les tests.
Générez la documentation pour les données de conceptions existantes, qu'il s'agisse de simples exigences ou de tableaux de traçabilité complexes.
Conforme et prêt pour l'audit.
Entièrement configurable en fonction de vos besoins spécifiques en matière de dispositifs et de réglementation.
Enable continuous deployment capabilities by connecting your software development tools with an ALM and eliminate error-prone manual processes across your product lifecycle management activities.
Native integrations with popular DevOps tools like Jira, GitHub, GitLab, Azure DevOps, and Confluence for code management, testing tools, and more.
Build your own with our REST API that has documentation for every part of the Matrix software so you can build a connection to your other tools.
Simplify processes with our SDK that makes it easier for developers to create their own applications and customizations and includes examples for custom Matrix extensions.
Keep software development on track with the Matrix Marketplace that lets you discover compatible plugins, templates, modules, and dashboards and install them directly in your instance.
Leverage vetted and tested add-ons that expand the functionality of your application lifecycle management (ALM).
Learn best practices and unique use cases for the different add-ons and modules and take full advantage of your ALM software application.
Install ALM project templates to set up teams and processes with a structure that supports governance, maintenance and calibration plans, and ensures compliance with regulations.
Clear visibility throughout the product development lifecycle using an application lifecycle management (ALM) solution that connects to your project management tools, lifecycle management tools, and code repositories.
Centralize information in an ALM for a unified view to ensure project managers, developers, and engineers are leveraging the same data to reduce errors and inconsistencies.
Mitigate risk by identifying and addressing issues early in the development lifecycle that aren’t in compliance with your regulatory framework.
Simplify traceability with application lifecycle management (ALM) software that creates transparent and auditable links between all elements of the software development process.
Increase productivity by enabling teams to work on multiple product releases in parallel, fix bugs, and work on prototype ideas without affecting the main code with the Branching & Merging module.
Get market-specific or multi-variant products to market faster by working in parallel on multiple versions in branches of the documentation.
Quickly and compliantly fix bugs in a branch from a past release and merge the fixes back when needed.
Document requirements, specifications, and tests for new features in a branch until they are ready for integration.
Get more products out the door by combining existing items like requirements, user needs, and test cases from existing projects for reuse in other projects using the Compose module.
Keep items error-free and identical by pushing updates made in the source project across to all your projects that maintain traces without needing to relink them.
Quickly copy modifiable items into new projects in your application lifecycle management (ALM) software and adapt them without starting from scratch to accelerate your team's productivity.
Improve collaboration with icons that show which project items are being used in other projects to ensure team alignment from inception to deployment.
Achieve complete mastery over quality assurance, design, requirements, and technical documentation throughout the product lifecycle while ensuring that all employees are following the appropriate quality standards.
Create ultra-efficient digital workflows to replace archaic paper quality management and application lifecycle management processes using flexible and reusable templates.
Be up and running in days with a QMS based on the same design philosophy as your application lifecycle management (ALM) software so it’s easy to onboard new users.
Simplify compliance throughout the software development process from standards, requirements engineering, testing, and more with tools that bridge the gap between engineering and quality teams.
Go beyond standard application support with the platinum support package that helps you streamline compliance management in your ALM.
Get best-in-class support from industry experts and support engineers for all your needs with a dedicated block of monthly hours that can be rolled over.
Request consulting services, audits of your Matrix system, cybersecurity guidance, training for new users, and more whenever you need it.
Get up and running fast with support for importing and converting data, creation of custom scripts, and API support.
Témoignages clients
"Avec MatrixALM, nous pouvons générer des documents PDF au même format qu'auparavant de manière hautement automatisée, ce qui améliore l'efficacité de notre équipe d'environ 60 %."
Hans-Jurgen Schneider, Project Manager
Caractéristiques principales
Assurez votre réussite grâce à des fonctionnalités clés de gestion du cycle de vie conçues pour SxMD.
Démo