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Matrix Req for

Diagnostic Equipment with Matrix Req

As diagnostic technology evolves, so do the expectations for traceability, documentation, and compliance. Matrix Req empowers development teams to meet these demands.

Matrix Requirements
The challenge
Our solution

Diagnostic equipment demands precision — in design and in documentation

A structured platform for diagnostic device development from design input to submission

  • Complex, multi-disciplinary design:

    • Diagnostic equipment often combines hardware, software, and connectivity — each with its own compliance requirements that must be managed together.

  • Maintain full traceability

    • from user needs to design outputs, tests, and risk controls — across hardware, software, and connectivity components.

  • Strict performance and safety standards:

    • Meeting IEC 60601, IVD regulations, and regional requirements requires structured, traceable development processes from day one.

  • Stay compliant

    • with IEC 60601, IVD regulations, EU MDR, FDA, and other applicable standards in a single platform.

  • Growing documentation burden:

    • Regulatory submissions for diagnostic devices require comprehensive technical files that are difficult to assemble and maintain without a dedicated system.

  • Accelerate submissions

    • with automatically generated, audit-ready technical documentation.

    The challenge

    Diagnostic equipment demands precision — in design and in documentation

  • Complex, multi-disciplinary design:

    • Diagnostic equipment often combines hardware, software, and connectivity — each with its own compliance requirements that must be managed together.

  • Strict performance and safety standards:

    • Meeting IEC 60601, IVD regulations, and regional requirements requires structured, traceable development processes from day one.

  • Growing documentation burden:

    • Regulatory submissions for diagnostic devices require comprehensive technical files that are difficult to assemble and maintain without a dedicated system.

    Our solution

    A structured platform for diagnostic device development from design input to submission

  • Maintain full traceability

    • from user needs to design outputs, tests, and risk controls — across hardware, software, and connectivity components.

  • Stay compliant

    • with IEC 60601, IVD regulations, EU MDR, FDA, and other applicable standards in a single platform.

  • Accelerate submissions

    • with automatically generated, audit-ready technical documentation.

    Core Features

    Purpose-built capabilities for diagnostic equipment development teams.

    End-to-End Design ControlManage all design elements: inputs, outputs, tests, and risks in a structured, traceable database. Link every design decision to its regulatory rationale and keep your design history file always up to date.
    Multi-Disciplinary TraceabilityMaintain traceability across hardware, software, and connectivity components in a single project. Instantly surface the impact of any change across your full design from component level to system level.
    Risk Management for Diagnostic DevicesConfigure risk assessments tailored to your device type and classification — with support for ISO 14971 workflows, pre- and post-control assessments, and full traceability between risks and mitigations.
    Regulatory Standards CoverageNavigate IEC 60601, IVD regulations, EU MDR, FDA 510(k), and other regional requirements with confidence with built-in support for the documentation and traceability these standards demand.
    Technical Documentation GenerationGenerate audit-ready technical files automatically from your live project data in PDF, Word, or HTML and archive them securely for regulatory submissions.

    Hear from our customers

    With Matrix Req, we avoid all the challenges of using manual or custom-developed tools. Instead, we get a purpose-built solution that’s designed by medical device experts, enabling much faster ISO 13485 compliance.”

    François Audéon, Chief Technology Officer

    Matrix One is trusted by 500+ Life Sciences & Medical Device Companies