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Surgical Instruments with Matrix Req

Surgical instrumentation must meet stringent design controls and documentation standards. Matrix Req provides a robust framework to manage their inherent complexities.

Matrix Requirements
The challenge
Our solution

Surgical instruments demand precision — in the operating room and in documentation

A structured platform that keeps pace with surgical instrument complexity

  • Wide device complexity:

    • Managing development across manual instruments, minimally invasive devices, and robotic surgical systems requires a flexible, structured approach that most tools can't support.

  • Maintain full traceability

    • from design inputs to outputs, verification, and risk controls — across hardware, electronics, and embedded software.

  • Stringent safety and compliance requirements:

    • Meeting ISO 14971, IEC 60601-1, EU MDR, and FDA requirements simultaneously demands structured traceability from design input to final verification.

  • Stay compliant

    • with ISO 14971, IEC 60601-1, EU MDR, FDA, and other applicable standards in one platform.

  • Reuse and sterilization documentation:

    • Tracking material specifications, sterilization validations, and reprocessing instructions accurately is time-consuming and error-prone without a dedicated system.

  • Accelerate submissions

    • with structured documentation generated automatically from your live project data.

    The challenge

    Surgical instruments demand precision — in the operating room and in documentation

  • Wide device complexity:

    • Managing development across manual instruments, minimally invasive devices, and robotic surgical systems requires a flexible, structured approach that most tools can't support.

  • Stringent safety and compliance requirements:

    • Meeting ISO 14971, IEC 60601-1, EU MDR, and FDA requirements simultaneously demands structured traceability from design input to final verification.

  • Reuse and sterilization documentation:

    • Tracking material specifications, sterilization validations, and reprocessing instructions accurately is time-consuming and error-prone without a dedicated system.

    Our solution

    A structured platform that keeps pace with surgical instrument complexity

  • Maintain full traceability

    • from design inputs to outputs, verification, and risk controls — across hardware, electronics, and embedded software.

  • Stay compliant

    • with ISO 14971, IEC 60601-1, EU MDR, FDA, and other applicable standards in one platform.

  • Accelerate submissions

    • with structured documentation generated automatically from your live project data.

    Core Features

    Purpose-built capabilities for surgical instrument development teams.

    ISO 14971 & IEC 60601-1 Compliance SupportAlign risk management and electrical safety standards within your development process — with structured workflows, documentation, and traceability that support global regulatory approval.
    Design Control & TraceabilityEnsure every design input, output, verification, and validation activity is traceable and audit-ready — from concept through to finished product. Keep your Design History File always current and complete.
    Robotic & Software-Integrated Device SupportManage hybrid development involving hardware, electronics, and embedded software in robotic and software-driven surgical systems — maintaining full traceability across all components in a single project.
    Reuse & Sterilization DocumentationTrack material specifications, sterilization validations, and reprocessing instructions with precision and consistency — ensuring your documentation meets regulatory expectations for reusable devices.
    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