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Implantable Devices with Matrix Req

Implantable device products must meet the highest standards of biocompatibility, safety, and performance. Matrix Req delivers the end-to-end support needed to navigate these demanding lifecycles.

Matrix Requirements
The challenge
Our solution

Implantable devices carry the highest regulatory and safety burden in MedTech

End-to-end support for the full implantable device lifecycle

  • Highest-risk classification:

    • Implantable devices are typically Class III, requiring clinical evidence, extensive technical documentation, and rigorous pre-market approval across multiple jurisdictions.

  • Maintain full traceability

    • across materials, electronics, software, and clinical validation — in one connected project.

  • Biocompatibility and material traceability:

    • Every material, coating, and sterilization process must be fully documented and traceable — with no room for gaps.

  • Stay compliant

    • with ISO 14971, ISO 14708, ISO 5840, EU MDR, FDA, and other applicable standards.

  • Lifecycle complexity:

    • Compliance doesn't end at market approval. Post-market surveillance, vigilance reporting, and design change management must be maintained throughout the device's entire lifecycle.

  • Extend traceability into post-market

    • with integrated feedback and vigilance reporting support via the eQMS module.

    The challenge

    Implantable devices carry the highest regulatory and safety burden in MedTech

  • Highest-risk classification:

    • Implantable devices are typically Class III, requiring clinical evidence, extensive technical documentation, and rigorous pre-market approval across multiple jurisdictions.

  • Biocompatibility and material traceability:

    • Every material, coating, and sterilization process must be fully documented and traceable — with no room for gaps.

  • Lifecycle complexity:

    • Compliance doesn't end at market approval. Post-market surveillance, vigilance reporting, and design change management must be maintained throughout the device's entire lifecycle.

    Our solution

    End-to-end support for the full implantable device lifecycle

  • Maintain full traceability

    • across materials, electronics, software, and clinical validation — in one connected project.

  • Stay compliant

    • with ISO 14971, ISO 14708, ISO 5840, EU MDR, FDA, and other applicable standards.

  • Extend traceability into post-market

    • with integrated feedback and vigilance reporting support via the eQMS module.

    Core Features

    Purpose-built capabilities for implantable device development teams.

    Long-Term Risk & Safety ManagementComprehensively document and manage risk in accordance with ISO 14971 and device-specific standards such as ISO 14708 and ISO 5840 — covering the full device lifecycle from design through post-market activities.
    Biocompatibility & Material TraceabilityMaintain full traceability of materials, coatings, and sterilization processes to support biocompatibility requirements and implant safety documentation — with no gaps in your design history.
    Complex System EngineeringCoordinate interdisciplinary development across electronics, software, mechanical design, and clinical validation in a unified environment — keeping all teams aligned and all artifacts traceable.
    Post-Market Surveillance IntegrationExtend traceability into post-market feedback and vigilance reporting to support ongoing compliance and lifecycle improvements — fully integrated via the eQMS module.
    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