Start With Prebuilt Software
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
A Connected Medical Device Software Platform
Prebuilt, Configurable Software Platform
Device Integration & Verification
Software Process & Documentation
Built under an ISO-13485 Certified QMS
Don’t Build Your Medtech Software from Scratch
Start with NEX: A regulatory-ready, prebuilt software foundation backed by Sequenex engineering expertise, quality-controlled development processes, and the documentation needed to move your product forward.
Delivered in your infrastructure with complete source code—so you stay in control.
Your product. Your data. Your infrastructure.
Configure NEX for Your Product
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, modern medtech engineering, quality-controlled development, and documentation in one foundation — reducing the time, cost, and risk of building 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 product evolution.
AI-Accelerated. Engineer-Controlled.
AI-assisted workflows accelerate the medical-device software lifecycle—from planning, risk analysis, and requirements through development, testing, traceability, and DHF completion.
AI accelerates the work; qualified engineers retain control. Every regulated output undergoes human review, verification, and approval within the Sequenex ISO 13485-certified QMS.
One Foundation for All of Your Milestones
A rapid product development 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.
Rapid Prototype/POC
Start with a customer-owned, prebuilt software foundation.
Sequenex engineering integrates your device and configures the mobile, cloud, and web components for your brand and workflows—creating working software that collects and displays real-time device data.
Demonstrate a functioning product workflow, validate technical feasibility, and carry the same foundation forward into clinical and commercial development.Clinical Studies
Build on the same software foundation as your product advances into clinical studies.
Sequenex engineering configures the system for your investigational device and study requirements, then provides the traceability, verification evidence, and software documentation needed to support clinical study authorization and future regulatory submissions.Regulatory Submission
Advance the same connected software and product-specific documentation toward regulatory submission.
Sequenex engineering aligns the system with submission-stage requirements, intended use, and risk controls, and completes the traceability, verification evidence, and software documentation needed to support submissions.Commercialization
Deploy your software in your infrastructure as your product moves to market—without rebuilding the foundation.
Sequenex engineering supports production deployment, security, monitoring, updates, and ongoing software changes under design controls.
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
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SaMD and Connected Devices Software Experts
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