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Agile & Audit ready SxMD with MatrixALM.

Control Medical Device design with an agile all-in-one solution for SxMD. 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 software platform designed to bridge the gap between quality and compliance.

Streamline & Centralize Requirements Management

Build Medical Devices with full traceability across design inputs and outputs.

  • Capture, document and manage all requirements on multiple layers.

  • Live Traceability Verification.

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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.

  • Manage and link cyber security threats to safety risks.

  • Seamlessly integrate risk control into design input.

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Verification and Validation

Multi-layer requirements verification and validation testing throughout the design process.

  • Speed up test execution and manage test scripts at scale.

  • Integrate with development tools to automate tests.

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Centralize Documentation

Generate documentation for existing design inputs & outputs from simple requirements to complex trace tables.

  • Part 11 compliant and audit-ready.

  • Fully configurable for your Medical Device needs.

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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 ~60%."

Hans-Jurgen Schneider, Project Manager

Core Features

Ensure success with key application lifecycle management capabilities built for SxMD.

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 Identify broken, missing or outdated traces.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.
Data Hierarchy StructureDesign items are stored in a tree structure that makes it easy to find and organize information.
Agile Sync ModuleSynchronize documentation between Matrix and the other tools you work in like, Confluence, TFS, JIRA.
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Request a demo

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