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Nex for Medtech

NEX: The Prebuilt Software Platform for MedTech

Core Infrastructure & Functionality Prebuilt
Engineered under ISO 13485-Certified QMS
MVP → Clinical → Commercial
Device-Agnostic Architecture
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NEX Platfrom Medtech

Focus on Your Device. Not the Software.

Start at 80% complete with core infrastructure and functionality already in place.

  • A Complete Software Foundation for Your Product

    NEX includes prebuilt iOS & Android apps, Patient & Clinician Dashboards, an Administrator Portal, and Secure Cloud Infrastructure for medical data.

  • Collect Device Data Fast

    Integrate your device and begin collecting CGM, biosensor, wearable, and connected device data in weeks through prebuilt mobile apps and secure cloud infrastructure.
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Why Choose NEX?

Delivered Faster. Owned by You.  

 

Built for Regulated Medical Devices

Developed under an ISO 13485-certified QMS in accordance with IEC 62304 and ISO 14971.

Each implementation includes tailored documentation aligned to your intended use and risk profile, structured for integration into your Design History File (DHF).

Start Ahead, Not From the Ground Up

NEX provides a prebuilt foundation for the core infrastructure and basic features required by biosensor, wearables and connected device products, so you can invest more in the capabilities that make your device unique.

 

Owned by You

NEX is deployed as your own code base, giving you full control over your product roadmap, regulatory strategy, data, architecture, and long-term evolution.

 

 

Engineered for Acceleration

AI-assisted workflows support development, testing, and documentation.

All outputs are subject to engineer review, verification, and approval under formal design controls.

NEX platfrom all development stages

One Foundation: from MVP to Commercial

Accelerate time to market with NEX—built to support regulated product development from day one.
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  • Prototype

    Start collecting real device data immediately with NEX, using a production-grade foundation. No "throwaway" prototypes.

  • MVP

    Extend NEX to support user workflows and investor-ready demos—without rebuilding your data layer.

  • Pre-Clinical & Clinical

    Use NEX to support preclinical validation, feasibility, and IDE clinical studies with consistent data and traceability.

  • Commercial

    Confidently scale to commercial deployment. No migrations. No re-architecture. Confidently accelerate your time to market.
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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

    NEX provides a complete, prebuilt foundation for your product—extended and configured to your device and use case. Our team supports implementation, integration, and ongoing evolution so you can move forward without rebuilding your software.


  • Regulatory Ready

    NEX Prebuilt Features

    Secure & Compliant Cloud Infrastructure

    Secure infrastructure for healthcare applications, with encrypted data handling, access controls, audit logging, and resilient backup and recovery.

    Designed to support HIPAA and GDPR requirements where applicable.

  • ISO 13485 Certified QMS

    NEX is developed and maintained under an ISO 13485–certified Quality Management System, with controlled design, verification, validation, and change management processes.

    Design History File (DHF) Ready

    Each implementation includes structured documentation for your Design History File (DHF), including requirements, traceability, V&V, risk artifacts, and SBOM.

  • Design Controls

    Software development follows IEC 62304 with risk management under ISO 14971—ensuring traceable, controlled, and repeatable development.

    Built-In Compliance Features

    System-level controls including role-based access, audit trails, and electronic record management—supporting compliant operation of your product.

    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

  • NEX + Sequenex Engineering

    NEX provides the foundation. Sequenex engineering configures, extends, and delivers product software for your device.

  • Controlled Change Management

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

  • Regulatory Continuity

    Maintain design history, risk management, and lifecycle documentation as your product evolves.  We work with your Quality/Regulatory.

  • Scalable Product Development

    Expand your product using an established foundation, with engineering support as needed—without rebuilding or overextending internal teams.

  • 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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