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Dental Devices with Matrix Req

Dental devices products must combine biocompatibility, mechanical durability, and patient-specific customization while adhering to strict regulatory standards. Matrix Req supports the complete development cycle of dental technologies.

Matrix Requirements
The challenge
Our solution

Dental device development spans a wide spectrum with uncompromising compliance requirements

A single platform for the full dental device development lifecycle

  • Biocompatibility and material validation:

    • Every material and coating used in implants and appliances must be fully documented and validated for long-term safety — with no gaps in traceability.

  • Maintain full traceability

    • from design inputs to outputs, verification, and risk controls — across materials, components, and product variants.

  • Patient-specific and modular complexity:

    • Managing custom and configurable device variants while maintaining regulatory compliance adds significant overhead to design control.

  • Stay compliant

    • with EU MDR, FDA 21 CFR Part 820, ISO 13485, and other applicable standards in one platform.

  • Multi-market regulatory burden:

    • Meeting EU MDR, FDA 21 CFR Part 820, ISO 13485, and device-specific standards simultaneously requires structured, traceable documentation across jurisdictions.

  • Manage customization confidently

    • from standard products to patient-specific configurations — with reusable, traceable design elements.

    The challenge

    Dental device development spans a wide spectrum with uncompromising compliance requirements

  • Biocompatibility and material validation:

    • Every material and coating used in implants and appliances must be fully documented and validated for long-term safety — with no gaps in traceability.

  • Patient-specific and modular complexity:

    • Managing custom and configurable device variants while maintaining regulatory compliance adds significant overhead to design control.

  • Multi-market regulatory burden:

    • Meeting EU MDR, FDA 21 CFR Part 820, ISO 13485, and device-specific standards simultaneously requires structured, traceable documentation across jurisdictions.

    Our solution

    A single platform for the full dental device development lifecycle

  • Maintain full traceability

    • from design inputs to outputs, verification, and risk controls — across materials, components, and product variants.

  • Stay compliant

    • with EU MDR, FDA 21 CFR Part 820, ISO 13485, and other applicable standards in one platform.

  • Manage customization confidently

    • from standard products to patient-specific configurations — with reusable, traceable design elements.

    Core Features

    Purpose-built capabilities for dental device development teams.

    MDR, 21 CFR Part 820 & ISO 13485 Compliance SupportEnsure full compliance with EU, US, and global regulatory frameworks for dental devices and quality systems — with structured workflows, documentation, and traceability built for regulatory submissions.
    Custom & Configurable Device SupportManage modular designs and patient-specific adaptations with traceable requirements and streamlined documentation workflows — maintaining compliance across your full product range.
    Biocompatibility & Material ValidationTrack materials and coatings used in implants and appliances to support long-term safety, biocompatibility requirements, and regulatory approvals — with full traceability across all design elements.
    Full Lifecycle DocumentationMaintain traceability from initial concept through clinical evaluation, manufacturing, and post-market activities — in a single, integrated platform that keeps your design history always current and audit-ready.
    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