Compliant SxMD with MatrixALM.

Control Medical Device design with an agile all-in-one ALM solution for SaMD. Easily manage technical documents, tests & risks to ensure audit readiness.

Trusted by 200+ SxMD & Medical Device Companies

Accelerate time to market

Easy to use, flexible application lifecycle management software platform designed to bridge the gap between quality and compliance.

Streamline & Centralize Requirements Management

Build Medical Devices with end-to-end traceability from development to deployment across the entire product lifecycle.

  • Capture, document, and manage all requirements in a centralized repository making it easy for teams to access, review, and update them throughout the product lifecycle. 

  • Pass any audit, compliance, or regulatory inspection with live traceability that shows who did what, when, and why at an item-based granular level. 

  • Eliminate bottlenecks with automated notifications and workflows that help foster communication and collaboration among modern software development teams and quality assurance teams. 

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Matrix ALM
Risk Management aligned with ISO 14971

Build tailored risk documentation based on procedures fully configurable to meet any Medical Device need directly in your application lifecycle management (ALM) software.

  • Ensure all risk-related activities are documented and traceable throughout the development processes by linking risks to requirements, design elements, test cases, and issues reports.

  • Plan, execute, and track risk mitigation activities with dashboards that show detailed information for your risk matrix and RBM and RAM stats. 

  • Create unique risk matrices to assess risk at varying levels of granularity, for different projects or different phases of software development for better overall project outcomes.

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Multi-layered verification and validation testing

Immerse your design process in robust, multi-layered verification and validation testing to confirm your product meets requirements and fulfills its intended purpose flawlessly.

  • Connect your DevOps toolkit to automate test executions and manage text scripts with unparalleled efficiency without compromising on quality. 

  • Support compliance using an application lifecycle management (ALM) solution that tracks the entire V&V process with detailed reports and audit trails. 

  • Reduce application development costs and time with early detection of issues through continuous integration, continuous delivery and testing with an ALM that tracks testing activities systematically.

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Centralize documentation for quality assurance

Work in your tools of choice and generate documentation for existing design inputs and outputs from simple requirements to complex trace tables in the application lifecycle management (ALM) solution in a few clicks.

  • Easily create Part 11 compliant eSignatures built into the ALM system to streamline release management and documentation.

  • Improve collaboration by providing cross-functional teams with a single source of truth for the project so teams can be assured their working with up-to-date information.

  • ALM tools to leverage flexible templates for different documentation needs to help teams have the assurance that they’re including all the necessary information. 

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Integrate with your mission-critical applications

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.

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Faster solutions and implementation

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, ensures compliance with regulations, and streamlines software delivery.

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Enhance quality with a single source of truth ALM platform

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. 

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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 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. 

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Supercharge product development while maintaining traceability

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. Enhance your process with robust test management to track and manage test cases effectively.

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MatrixQMS + MatrixALM

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. 

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Elevated support services for rapid implementation and guidance

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. 

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Hear from our customers


"With MatrixALM, we can generate PDF documents in the same format as before in a highly automated way, improving our team’s efficiency by an estimated 60%."

Hans-Jurgen Schneider, Project Manager

Core ALM Features

Ensure success with key application lifecycle management (ALM) capabilities built for SxMD for teams who follow agile development, v, or waterfall.

Risk ModuleDefine risks and risk mitigation according to customizable templates and formulas.
Test ModuleDefine, plan, and execute multiple test cycles.
TraceabilityStandard traces are defined. Configure traceability between items as optional or required. Identify broken, missing, or outdated traces.
Full Audit LogAll changes are automatically logged with user identity and timestamp. Compare revisions side by side to quickly see the changes and restore previous versions.
Data Hierarchy StructureDesign items are structured in folder trees that make it easy to find and organize information.
Agile Sync ModuleSynchronize documentation between Matrix and the other tools you work in like Confluence, TFS, and Jira.
See all ALM features

Request an ALM demo

Take a tour with us to see how you can better document requirements, faster with Matrix Requirements.