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Nex for Medtech

NEX: The Prebuilt Software Platform for MedTech

Prebuilt Mobile, Cloud & Device Platform
Engineered under ISO 13485-Certified QMS
MVP → Clinical → Commercial
Device-Agnostic Architecture
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NEX Platfrom Medtech

Build Your Device. Not the Software Stack

Sequenex Engineering customizes the NEX platform to align with your defined requirements and intended use.

  • A Complete Software Foundation 

    Prebuilt and regulatory-ready for connected medical devices and wearables. NEX provides a complete product software stack: mobile apps, secure cloud services, dashboards, device connectivity, and administrative tools.

  • Collect, Analyze and Display Real-Time Data in just weeks

    Capture CGM, biosensor, wearable, and connected medical device data through a secure, production-ready mobile and cloud platform. NEX enables real-time ingestion and presentation within a configurable, regulatory-ready software stack. Deploy product software in weeks, not months.
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Why Choose NEX?

Delivered faster. Owned by you.

Regulatory Ready

Executed in accordance with IEC 62304 within our ISO 13485:2016–certified QMS, with risk management performed per ISO 14971. Each implementation includes a software documentation package structured for inclusion in your Design History File (DHF).

Purpose Built for Connected Medical Devices

NEX provides a complete product software stack: mobile apps, secure cloud services, dashboards, device connectivity, and administrative tools.

Don’t build what’s already been engineered. 

Owned by You

NEX is delivered as a complete system and deployed in your environment, giving you full control over your product roadmap, regulatory strategy, data, architecture, and long-term evolution.

 

 

Engineered for Acceleration.

NEX combines a prebuilt software foundation with AI-assisted engineering workflows that help accelerate code development, test generation, and documentation. All outputs are reviewed and validated by engineers under structured design controls to ensure quality and regulatory rigor.

Move faster while maintaining full traceability, verification discipline, and engineering oversight.

NEX platfrom all development stages

One Foundation: from MVP to Commercial

Start with a regulatory-compliant, prebuilt foundation. Reduce time, reduce cost, move ahead faster.
See NEX framework

  • Prototype

    Quickly develop and test prototypes to validate your concepts before full-scale development.

  • MVP

    Develop Minimum Viable Products (MVPs) efficiently to test market readiness and demonstrate your product to investors.

  • Pre-Clinical & Clinical

    Support preclinical validation, early feasibility, and IDE clinical studies within a controlled software lifecycle environment.

  • Commercial

    Confidently scale up to full commercial applications using our
    reliable prebuilt infrastructure.
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  • Rapid Time to Market

    Prebuilt and Customizable iOS & Android Apps, Secure Data Cloud, Dashboards, and Admin Portal: Start with a fully functional foundation. Configured and extended to fit your device’s unique requirements.

  • Full Service Software and Support

    Sequenex fast-tracks software delivery with regulatory expertise, end-to-end software engineering, custom development and prebuilt modules, and ongoing support.


  • Regulatory Ready

    NEX Prebuilt Features

    Secure & Scalable Cloud Architecture

    Secure infrastructure designed to support HIPAA requirements, with encrypted data handling, access governance, audit logging, real-time processing, and resilient backup and recovery controls.

  • ISO 13485 Certified QMS

    NEX is developed and maintained under Sequenex’s ISO 13485–certified Quality Management System, with documented design controls, verification, validation activities, and controlled change management.

    Structured Regulatory Artifacts

    Design-controlled, platform-generated regulatory artifacts — including requirements, traceability, V&V records, risk documentation, SBOM, and lifecycle documentation — structured for integration into your full system DHF

  • Design Controls

    Developed under our ISO 13485–certified QMS to satisfy FDA QMSR. Executed per IEC 62304 with risk management under ISO 14971, ensuring traceable, controlled development.

    Built-In Compliance Features

    Integrated governance controls — including role-based access, audit trails, electronic record traceability, and system-level logging — designed to support 21 CFR Part 11 requirements where applicable.

Customization and Flexibility

  • Configurable UI and Features

    Easily customize the platform’s user interface and functionalities to suit your specific needs and branding.

  • Adaptable Architecture

    Modify and expand the platform to meet the unique requirements of your device.
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  • A True Product Development Partner

  • Sequenex Engineering

    The Sequenex Engineering Team operates as an extension of your organization, delivering regulated software expertise across the product lifecycle.

  • Controlled Change Management

    Enhancements and modifications are executed under structured design controls, with impact analysis, testing, and full documentation.

  • Regulatory Continuity

    Preserve design history, risk management, and software lifecycle documentation as your product evolves.

  • Capital-Efficient Scaling

    Expand software capacity as your product grows, without the cost and complexity of building an in-house regulated engineering organization.

  • Cost and Resource Efficiency

Want to schedule a demo of NEX?

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SaMD and Connected Devices Software Experts
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