Built for regulated devices
Developed under an ISO 13485-certified QMS in accordance with IEC 62304 and ISO 14971, with DHF-aligned documentation.
NEX Platform · Medtech
NEX for Medtech
The prebuilt software platform for regulated medical devices and SaMD. Start at 80% complete — prebuilt iOS/Android apps, patient and clinician dashboards, admin portal, and secure cloud, engineered under an ISO 13485-certified QMS to IEC 62304 with regulatory documentation generated during development.
Why choose NEX? Delivered faster. Owned by you.
Start ahead, not from the ground up
The prebuilt foundation covers core infrastructure — invest your resources in the capabilities that differentiate your device.
Owned by you
NEX is deployed as your own code base: full control over roadmap, regulatory strategy, data, and architecture.
Engineered for acceleration
AI-assisted workflows for development, testing, and documentation — all subject to engineer review under design controls.
One foundation: from MVP to Commercial
Built to support regulated product development from day one — no throwaway prototypes, no migrations.
01 · Prototype
Start collecting real device data immediately on a production-grade foundation.
02 · MVP
Extend NEX for user workflows and investor demos without rebuilding the data layer.
03 · Pre-clinical & clinical
Support validation, feasibility, and IDE studies with consistent data and traceability.
04 · Commercial
Scale confidently without migrations or re-architecture.
Features & benefits
Rapid time to market
Prebuilt, customizable iOS/Android apps, secure data cloud, dashboards, and admin portal.
Secure & compliant cloud
Encrypted data handling, access controls, audit logging, backup/recovery — supporting HIPAA and GDPR where applicable.
DHF-ready
Structured documentation: requirements, traceability, V&V, risk artifacts, SBOM.
Design controls
Software development follows IEC 62304 with risk management under ISO 14971; 21 CFR Part 11 features where applicable.
Customization & flexibility
Configurable UI and features for your branding; adaptable architecture for unique device requirements.
A true product development partner
NEX provides the foundation; Sequenex configures, extends, and delivers your product software under controlled change management.