NEU!! Entwickelt SxMDs mit einem strukturierten eQMS, einschließlich auditfähriger SxMD-Vorlagen, die an EU- und US-Standards angepasst sind. Mehr Erfahren!
Compliant SxMD mit MatrixALM
Steuert das Design eurer Medizinprodukte mit einer agilen All-in-One-Lösung für Software als Medizinprodukt (SaMD). Verwaltet eure technischen Dokumente, Tests und Risiken mühelos, um Audit-Bereitschaft sicherzustellen.
Beschleunigte Marktzulassung
Benutzerfreundliche, flexible Softwareplattform, entwickelt, um die Kluft zwischen Qualität und Compliance zu überbrücken.
Erstellt eure Medizinprodukte mit vollständiger Rückverfolgbarkeit von Design Input bis Output.
Erfasst, dokumentiert und verwaltet alle Anforderungen auf mehreren Ebenen.
Echtzeit-Rückverfolgbarkeits-Verifikation
Erstellt maßgeschneiderte Risk-Dokumentationen basierend auf vollständig konfigurierbaren Verfahren, um jeglichen Bedarf im Bereich der Medizinprodukte zu erfüllen
Verwaltet und verknüpft Cybersecurity Gefahren mit Sicherheitsrisiken
Integriert nahtlos Risk-Kontrollen in den Design Input.
Mehrstufige Anforderungsverifizierung und Validierungstests zu jeder Zeit während des Designprozesses.
Beschleunigt die Testausführung und verwaltet Testskripte im großen Maßstab
Integration mit gängigen Entwicklungstools, um Tests zu automatisieren.
Erstellt Dokumentation für bestehende Design Inputs und Outputs von einfachen Anforderungsstrukturen bis hin zur komplexen Trace Tabelle.
Part 11 compliant und Audit gerecht.
Voll konfigurierbar basierend auf euren Produktvorgaben und regulatorischen Anforderungen
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.
Das sagen unsere Kunden
“Mit MatrixALM können wir unsere PDF Dokumentation im selben Format wie zuvor erstellen, jedoch auf stark automatisierte Weise, was die Effizienz unseres Teams um etwa 60% erhöht.”
Hans-Jürgen Schneider, Projektmanager
Kernfunktionen
Gewährleistet euren Erfolg mit essentiellen Qualitätsmanagementsystem-Funktionen, die auf SxMD zugeschnitten sind.
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