Start With Prebuilt Sofware
Regulatory-ready, configurable mobile apps, web dashboards, secure cloud infrastructure, APIs, device management, authentication, and common connected-device services are already built into NEX.
Nex for Medtech
NEX: Software for Connected Medical Devices
Prebuilt, Configurable Software Platform
Device Integration & Verification
Software Process & Documentation
Developed under ISO-13485 Certified QMS
Don’t Build Your Medtech Software From Scratch
No Software Team or Established Software Process? No Problem
Start with NEX: A prebuilt software foundation backed by engineering expertise, quality-controlled development processes, and the documentation needed to move your device forward.
Start with NEX: A prebuilt software foundation backed by engineering expertise, quality-controlled development processes, and the documentation needed to move your device forward.
Configure NEX for Your Product Today
We start with where your product is today — its requirements, hardware, workflows, and regulatory needs — then configure NEX to support what comes next without overbuilding.
A Faster, Lower-Risk Way to Build Medtech Software
NEX combines prebuilt software, medtech engineering, quality-controlled development, and documentation in one foundation — reducing the time, cost, and risk of building it all from scratch.
Built for Connected 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
Don’t build your software from scratch.
NEX provides a prebuilt starting point so you can focus on what differentiates your device: Your Data, Algorithms, and User Experience.
Core software capabilities are already in place within a controlled software foundation.
Owned by You
Your code. Your data. Your infrastructure.
NEX is delivered as your own code base, giving you full control over your product roadmap, 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.
One Foundation for All of Your Milestones
NEX is Sequenex’s configurable medtech software foundation, developed under our ISO 13485-certified QMS and configured for your device, intended use, and stage of development, with product-specific documentation carried forward as your product advances.
Prototype
Connect your device and start collecting real data on a production-grade software infrastructure you can carry forward as your product advances.Product Development
Configure NEX around your device, intended use, and workflows to support demos, pilots, and early validation—while building the product-specific requirements and documentation that carry forward.Pre-Clinical & Clinical
Use NEX as the software infrastructure for device-connected studies, with controlled data capture, traceability, and documentation to support study execution and investigational milestones such as an IDE.Commercial
Advance toward market release with product-specific engineering, verification, and software documentation to support 510(k), De Novo, or PMA submissions and commercialization.
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.
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.
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.
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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