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ISO 13485:2016 Certified QMS

Medical Device Software & SaMD Built Faster

Custom software for connected devices, biosensors, CGMs and wearables—backed by the processes, tools and technology to accelerate delivery.

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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?

Don’t Build from Scratch. Start with NEX.

NEX gives Medtech 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 (SDLC) 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).

 

ISO 13485-Certified Software Development 

Develop your medical-device software within an established ISO 13485-certified QMS without building the processes and documentation infrastructure internally. 

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