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ISO 13485 Certified QMS

Medical Device Software & SaMD Built Faster

Medical device software and SaMD development for connected devices, biosensors, CGM, and wearables.
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Connected medical device software on mobile applications
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Need to Get Your Device Software Up and Running Quickly?

Get Your Medical Device to Market Faster without Building the Software from Scratch

NEX gives medical device companies a proven starting point for mobile, cloud, device connectivity, and supporting software documentation — reducing development time, cost, and risk as you move from prototype through clinical and commercial development.

  • 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

    Connected medical device software for mobile, cloud, and real-time data, developed 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 for wearables and connected medical devices, spanning mobile apps, cloud services, and device connectivity.

     

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  • Conforms with IEC 62304 (SDLC)
  • Emphasizes Risk Management throughout Development Lifecycle (ISO 14971)
  • Complies with Regulatory Requirements
  • Ensures Traceability & 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 QMS is ISO 13485 Certified

Sequenex develops medical device software under an ISO 13485-certified QMS, with controlled design, verification, validation, risk management, and change control.

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