Connected MEdical Device Software
Medical Device Software & SaMD Built Faster
Don’t Build from Scratch. Start with NEX.
NEX gives Medtech companies a proven starting point for mobile, cloud, device connectivity, and supporting software documentation — reducing development time, cost, and risk as you move from prototype through clinical and commercial development.
Our Services
Explore the ways we help teams build, from connected device platforms and SaMD to biosensor and wearable software.
Connected Device Platforms
Learn MoreEnd-to-end engineering for hardware-plus-software products, covering sensor, firmware, mobile, cloud, and dashboards, delivered as one unified system rather than four bolted together.
Medical Device Software Development
Learn MoreConnected medical device software for mobile, cloud, and real-time data, developed under IEC 62304 (SDLC) within our ISO 13485-certified QMS.
Biosensor & CGM Software
Learn MoreMobile and cloud apps for biosensor, CGM, and connected diabetes products, from clinical-study software through commercial launch, backed by shipped clinical app experience.
SaMD Development
Learn MoreSoftware as a Medical Device engineered across a range of IMDRF risk classifications, with architecture, documentation, and validation aligned to your regulatory pathway.
AI in Medical Device Software Engineering
Learn MoreDesign-first engineering with AI accelerating implementation, documentation, and completeness checks, inside our ISO 13485-certified QMS.
- Conforms with IEC 62304 (SDLC)
- Emphasizes Risk Management throughout Development Lifecycle (ISO 14971)
- Complies with Regulatory Requirements
- Ensures Traceability & Accountability
Developed within our ISO 13485–certified QMS, we provide a complete software documentation package aligned to design controls and structured for inclusion in your Design History File (DHF).
ISO 13485-Certified Software Development
Develop your medical-device software within an established ISO 13485-certified QMS without building the processes and documentation infrastructure internally.
Knowledge Hub
Medical Device Software & SaMD Insights
Explore Knowledge Hub
October 21, 2026
Bolus Calculator Software: FDA Classification, Predicates and Design Requirements
Every bolus calculator recommendation is an insulin dose, so FDA regulates the software as a device. Here is which classification…
October 18, 2026
AI in Diabetes Devices: AID Algorithms, Glucose Prediction, and FDA Rules
AID algorithms, glucose prediction, and insulin dosing software are all called AI, but FDA regulates each by function. Here is…
October 10, 2026
FDA PCCP Guide for AI-Enabled SaMD: Contents, 510(k) Fit, Examples
A PCCP lets AI-enabled SaMD change after clearance without a new 510(k), if the plan is specific enough. Here is…
