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Cloud Connectivity, Compliance, and Security simplified.

Focus on pushing the boundaries of medical innovation while we take care of your compliance and security needs by connecting your medical device to the cloud.

Matrix Connect
The challenge
Our solution

Compliance shouldn't be a barrier to cloud connectivity

Built-in compliance so you don't have to build it yourself

  • Multiple standards to satisfy:

    • Meeting HIPAA, GDPR, HITRUST, ISO 13485, IEC 62304, and other requirements simultaneously is a major burden for engineering and regulatory teams.

  • Deploy with confidence

    • knowing your cloud connectivity already meets global regulatory requirements.

  • Data privacy across regions:

    • Protecting patient data in compliance with US and EU regulations requires different frameworks that must be maintained in parallel.

  • Protect patient data

    • with enterprise-grade security controls across all stages of handling and transmission.

  • Ongoing compliance maintenance:

    • Standards evolve — and keeping your infrastructure current with changing requirements adds continuous overhead to your team.

  • Stay ahead of changing standards

    • Matrix Connect maintains compliance so you don't have to.

    The challenge

    Compliance shouldn't be a barrier to cloud connectivity

  • Multiple standards to satisfy:

    • Meeting HIPAA, GDPR, HITRUST, ISO 13485, IEC 62304, and other requirements simultaneously is a major burden for engineering and regulatory teams.

  • Data privacy across regions:

    • Protecting patient data in compliance with US and EU regulations requires different frameworks that must be maintained in parallel.

  • Ongoing compliance maintenance:

    • Standards evolve — and keeping your infrastructure current with changing requirements adds continuous overhead to your team.

    Our solution

    Built-in compliance so you don't have to build it yourself

  • Deploy with confidence

    • knowing your cloud connectivity already meets global regulatory requirements.

  • Protect patient data

    • with enterprise-grade security controls across all stages of handling and transmission.

  • Stay ahead of changing standards

    • Matrix Connect maintains compliance so you don't have to.

    Core Features

    Every certification you need for worldwide success.

    HITRUST CSF r2 CertifiedMatrix Connect meets the HITRUST CSF r2 standard — the most widely recognized framework for healthcare cybersecurity. This certification covers controls from ISO 27001, SOC 2, HIPAA, and other security and privacy standards, ensuring your data is protected with industry-leading practices.
    ISO 13485:2016 CertifiedThe Matrix Connect platform is developed and operated under a robust ISO 13485:2016 certified quality management system — with development processes compliant with IEC 62304 and ISO 14971.
    HIPAA CompliantMatrix Connect adheres to HIPAA regulations, ensuring all personal health information is handled with the highest standards of privacy and security — across all stages of data handling and transmission.
    GDPR CompliantMatrix Connect complies with the General Data Protection Regulation (GDPR), ensuring personal data within the EU and UK is handled with full transparency, fairness, and accountability whether stored, transmitted, or processed.
    Global Regulatory CoverageOur customers have successfully received clearance and approval from the US FDA, CE Mark, EU MDR, IVDR, Health Canada, Australian TGA, and more selling their devices across all 6 continents with confidence.

    Every Certification You Need For Worldwide Success

    Global ReachOur customers sell their devices across all 6 continents and in multiple jurisdictions. Matrix Connect stays ahead of changing global compliance needs so you don't have to.
    Regulatory & Industry Standards CoveredAchieve compliance to regulatory and industry standards across design & development, security, and privacy arenas with a cloud connectivity solution that puts compliance at the center of our product 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