Skip to main content
Matrix Req for

Software as a Medical Device (SaMD) with Matrix Req

SaMD design must meet stringent standards based on demanding processes, and in recent years, regulations surrounding technical documentation have become stricter. Matrix Req fully addresses the challenges of this constrained design.

Matrix Requirements
The challenge
Our solution

SaMD compliance is uniquely complex — and getting stricter

One platform built for the full complexity of SaMD design

  • Multiple standards to satisfy

    • SaMD teams must navigate IEC 62304, ISO 14971, and regional regulations simultaneously — across all software risk classifications.

  • Stay compliant

    • across IEC 62304, ISO 14971, EU MDR, and FDA requirements — without switching tools.

  • Agile development vs. regulatory rigor

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

  • Move fast

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

  • Diverse system complexity

    • Whether standalone or integrated, SaMD requires a flexible framework that adapts to different architectures without losing compliance.

  • Scale across complexity

    • from standalone diagnostic software to embedded SaMD in larger medical devices.

    The challenge

    SaMD compliance is uniquely complex — and getting stricter

  • Multiple standards to satisfy

    • SaMD teams must navigate IEC 62304, ISO 14971, and regional regulations simultaneously — across all software risk classifications.

  • Agile development vs. regulatory rigor

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

  • Diverse system complexity

    • Whether standalone or integrated, SaMD requires a flexible framework that adapts to different architectures without losing compliance.

    Our solution

    One platform built for the full complexity of SaMD design

  • Stay compliant

    • across IEC 62304, ISO 14971, EU MDR, and FDA requirements — without switching tools.

  • Move fast

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

  • Scale across complexity

    • from standalone diagnostic software to embedded SaMD in larger medical devices.

    Core Features

    Purpose-built capabilities for SaMD teams navigating regulatory complexity.

    IEC 62304 Compliance SupportStreamline development and maintenance of SaMD with built-in support for IEC 62304 — covering software lifecycle processes, documentation, and traceability requirements.
    Class A, B & C Software ManagementHandle SaMD across all risk classifications in a single platform. Define classification-appropriate processes, documentation, and controls for each software system.
    Agile Methodology CompatibilityWork the way your team works. Matrix Req integrates seamlessly with Agile practices, enabling iterative development while maintaining the traceability and documentation regulators expect.
    Software System DiversityWhether your SaMD is standalone or integrated within a larger medical device, Matrix Req provides the flexible framework needed for efficient development and compliance across different system architectures.
    Monitoring & Diagnostic SoftwarePurpose-built support for monitoring and diagnostic SaMD applications — ensuring these critical solutions meet the highest regulatory and quality standards.

    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