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Matrix Req for

Therapeutic Devices with Matrix Req

Therapeutic devices demand uncompromising safety, reliability, and regulatory rigor. Matrix Req is purpose-built to support the development of therapeutic technologies.

Matrix Requirements
The challenge
Our solution

Therapeutic devices leave no room for error — in design or in compliance

A unified platform built for the complexity of therapeutic device development

  • Safety-critical complexity

    • High-risk functionalities like dosage control and respiratory support require rigorous, end-to-end verification and validation — with full traceability at every step.

  • Ensure full traceability

    • across hardware, firmware, and software — from user needs to design outputs, verification, and risk controls.

  • Hardware, firmware, and software integration

    • Managing requirements and design artifacts across interconnected systems is difficult without a unified platform.

  • Stay compliant

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

  • High regulatory burden

    • Complying with ISO 14971, IEC 60601-1, EU MDR, FDA, and other standards simultaneously requires structured processes that most tools can't support.

  • Accelerate submissions

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

    The challenge

    Therapeutic devices leave no room for error — in design or in compliance

  • Safety-critical complexity

    • High-risk functionalities like dosage control and respiratory support require rigorous, end-to-end verification and validation — with full traceability at every step.

  • Hardware, firmware, and software integration

    • Managing requirements and design artifacts across interconnected systems is difficult without a unified platform.

  • High regulatory burden

    • Complying with ISO 14971, IEC 60601-1, EU MDR, FDA, and other standards simultaneously requires structured processes that most tools can't support.

    Our solution

    A unified platform built for the complexity of therapeutic device development

  • Ensure full traceability

    • across hardware, firmware, and software — from user needs to design outputs, verification, and risk controls.

  • 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 therapeutic device development teams.

    ISO 14971 & IEC 60601-1 Compliance SupportAlign risk management and electrical safety standards within your development process. Matrix Req supports the structured workflows, documentation, and traceability these standards require for global regulatory approval.
    Embedded Software & Hardware TraceabilityLink requirements, design, and test artifacts across complex systems combining hardware, firmware, and software — maintaining full traceability across all components in a single project.
    Safety-Critical Functionality SupportEnsure high-risk functionalities — such as dosage control, alarm management, and respiratory support are thoroughly verified, validated, and traceable to their design inputs and risk controls.
    Real-Time Cross-Functional CollaborationKeep engineering, quality, and regulatory teams aligned with shared project visibility, structured review workflows, and change control tools built for dynamic, regulated development environments.
    Technical Documentation GenerationGenerate audit-ready design history files and technical documentation automatically from your live project data — in PDF, Word, or HTML — ready for regulatory submissions at any stage.

    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