Experience the ROI of time well spent.
Elevate productivity and compliance by efficiently managing technical documentation, tests, and risk to ensure audit readiness with a purpose-built, agile Application Lifecycle Management (ALM) system.
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Accélérer la mise sur le marché
Plateforme logicielle flexible et facile à utiliser, conçue pour combler le fossé entre l’agilité et la conformité.
Simplification et centralisation de la gestion des exigences
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.
Gestion des risques conforme à la norme ISO 14971
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.
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
Agile compliance and efficient risk mitigation in regulated environments
Comply with standards and regulations and mitigate risks faster while working in an agile way with an ALM built by Medical Device industry experts.
Centralize the management of DI/DO and seamlessly integrate risk control processes in line with ISO 14971 to enhance compliance and operational efficiency.
Drive faster, compliant product development from the start with full traceability that shows the relationship between requirements, specifications, risks, and test.
Develop safe and effective software in a purpose-built platform for documenting your development, testing, and V&V activities and meet IEC 62304 and IEC 82304 standards.
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
Harness compliance-driven design and quality processes
Simplify compliant requirements management and get to market faster with an easy-to-use and implement Application Lifecycle Management (ALM) solution that integrates with your mission-critical applications.
Leverage configurable templates that dynamically pull data from Matrix that trace to the standards that govern them to provide a compliant framework for design and quality processes.
Build plugins, extend the UI, create scripts, and manipulate data across your web applications faster with a REST API, SDK, and native integrations.
Save months on implementation by leaving it to us to import data, set up the structure, and train new users so that you can stay focused on innovation.
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
Démo