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ISO 13485 Certified QMS

Medical Device Software & SaMD Built Faster

Sequenex is a full-service medtech & SaMD software firm for the diabetes, biosensor, wearables and connected devices markets.
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Need to Get Your Device Software Up and Running Quickly?

NEX: A Prebuilt Foundation for Medical Device Software

Move from concept to regulated product faster, with mobile apps, cloud, device connectivity, and the documentation framework already in place.

  • Our Services

    Explore the ways we help teams build, from connected device platforms and SaMD to biosensor and wearable software.

    QA and Testing

    Connected Device Platforms

    End-to-end engineering for hardware-plus-software products, covering sensor, firmware, mobile, cloud, and dashboards, delivered as one unified system rather than four bolted together.

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  • Custom Software Development

    Medical Device Software Development

    End-to-end development of connected medical device software, spanning mobile, cloud, and real-time data, built under IEC 62304 within our ISO 13485-certified QMS.

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    Staff Augmentation and Dedicated Teams

    Biosensor & CGM Software

    Mobile and cloud apps for biosensor, CGM, and connected diabetes products, from clinical-study software through commercial launch, backed by shipped clinical app experience.

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  • Custom Firmware Development

    SaMD Development

    Software as a Medical Device engineered across a range of IMDRF risk classifications, with architecture, documentation, and validation aligned to your regulatory pathway.

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    Security and Privacy Solutions

    Wearables & Connected Device Software

    Custom software development for wearables and connected medical devices, spanning mobile apps, cloud, and device connectivity, built to integrate with the sensor and hardware your product runs on.

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  • Conforms with IEC 62304 (SDLC)
  • Emphasizes Risk Management throughout Development Lifecycle (ISO 14971)
  • Complies with Regulatory Requirements
  • Ensures Traceabilty & Accountability

 

Developed within our ISO 13485–certified QMS, we provide a complete software documentation package aligned to design controls and structured for inclusion in your Design History File (DHF).

 

The Sequenex ISO 13485 Certified QMS

Our ISO 13485 Certified QMS underscores our commitment to excellence in medtech software engineering, ensuring your projects are delivered with unparalleled precision and regulatory compliance.

View ISO 13485 Certificate
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