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Consumer Health Devices with Matrix Req

Matrix Req supports the development of consumer-facing medical technologies with a flexible, scalable platform.

Matrix Requirements
The challenge
Our solution

Consumer health devices must move fast without cutting corners on compliance

Move fast, stay compliant without choosing one over the other

  • Speed vs. compliance tension:

    • Fast-paced consumer development cycles are hard to reconcile with the structured documentation and traceability that regulators require.

  • Iterate quickly

    • with Agile-compatible workflows that maintain full traceability at every sprint.

  • Connectivity and interoperability complexity:

    • Managing requirements and risks related to Bluetooth, mobile apps, and cloud integrations across multiple platforms adds significant development overhead.

  • Stay compliant

    • with FDA, EU MDR, and other regional requirements — with documentation built for both Class I and II device submissions.

  • Usability and user experience requirements:

    • Consumer devices must meet IEC 62366-1 usability engineering standards — ensuring safe, effective experiences for non-clinical users.

  • Manage connectivity confidently

    • requirements and risks for Bluetooth, mobile apps, and cloud integrations, all in one platform.

    The challenge

    Consumer health devices must move fast without cutting corners on compliance

  • Speed vs. compliance tension:

    • Fast-paced consumer development cycles are hard to reconcile with the structured documentation and traceability that regulators require.

  • Connectivity and interoperability complexity:

    • Managing requirements and risks related to Bluetooth, mobile apps, and cloud integrations across multiple platforms adds significant development overhead.

  • Usability and user experience requirements:

    • Consumer devices must meet IEC 62366-1 usability engineering standards — ensuring safe, effective experiences for non-clinical users.

    Our solution

    Move fast, stay compliant without choosing one over the other

  • Iterate quickly

    • with Agile-compatible workflows that maintain full traceability at every sprint.

  • Stay compliant

    • with FDA, EU MDR, and other regional requirements — with documentation built for both Class I and II device submissions.

  • Manage connectivity confidently

    • requirements and risks for Bluetooth, mobile apps, and cloud integrations, all in one platform.

    Core Features

    Purpose-built capabilities for consumer health device development teams.

    Usability Engineering & IEC 62366-1 SupportIntegrate human factors and usability testing into your development process — ensuring your device delivers a safe and effective experience for everyday consumers, not just clinical users.
    Global Regulatory CoverageNavigate FDA, EU MDR, and other regional requirements confidently — with documentation and traceability that supports both Class I and II device submissions across global markets.
    Connectivity & Interoperability SupportManage requirements and risks related to Bluetooth, mobile apps, and cloud-based data integrations — keeping connectivity concerns fully traceable alongside your core device requirements.
    Rapid Iteration for Consumer MarketsEnable fast-paced development cycles while maintaining rigorous traceability and compliance — with Agile-compatible workflows that keep your team moving without creating documentation debt.
    Technical Documentation GenerationGenerate audit-ready technical files automatically from your live project data — in PDF, Word, or HTML — ready for regulatory submissions at any stage of development.

    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