A purpose-built medtech software foundation — delivered faster, owned by you.
NEX is developed within an ISO 13485–certified QMS and governed by formal software design controls aligned with IEC 62304 and ISO 14971.
The platform architecture includes configurable security, role-based access, and audit controls designed for HIPAA safeguards and 21 CFR Part 11.
NEX supports CGMs, biosensors, wearables, and connected medical devices. It delivers the full product software stack — mobile apps, secure cloud, and device integration. Don’t build what’s already been engineered. Deploy NEX and reduce development time by up to 80%.
We build the software. You own the product. NEX is delivered as a complete system and hosted in your environment, giving you full control over your product roadmap, data, architecture, and long-term evolution. NEX adapts to your strategy and workflows, allowing you to move forward without external constraints on how your product grows over time.
By starting with a purpose-built foundation and working with a team experienced in medtech software, companies can avoid years of duplicated effort and reduce development time and cost by up to ~80% compared with building equivalent capabilities from scratch.
Compliant with regulatory requirements and customizable. NEX includes robust “out of the box” features and functionality and allows for a wide variety of customizations. Start your project at 80% done!
HIPAA-Compliant Storage, End-to-End Data Encryption, Real Time Data Processing, Comprehensive Cybersecurity Protocols, Data Back Up and Recovery
NEX has been engineered, validated and tested under Sequenex’s ISO 13485 Certified Quality Management System, ensuring adherence to the highest regulatory standards in the industry.
We provide tailored and required regulatory documentation (DHF, SRS, V&V) to streamline compliance and support your product.
The NEX platform complies with 21 CFR 820.30, IEC 62304 and ISO 14985 ensuring all aspects of the software development process and any modifications are documented and controlled.
The NEX platform includes features to maintain continuous compliance with industry standards and regulations, including automated data logging, traceability, and audit trails.
Sequenex operates as an extension of your organization, delivering regulated software expertise across the product lifecycle.
Enhancements and modifications are executed under structured design controls, with impact analysis, testing, and full documentation.
Preserve design history, risk management, and software lifecycle documentation as your product evolves.
Expand software capacity as your product grows, without the cost and complexity of building an in-house regulated engineering organization.
