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Medical Device Development

We develop our own connected diagnostic and monitoring devices — hardware, firmware and SaMD — and bring that clearance-ready discipline to partner programs.

Overview

What we deliver

EldoNova+ is a device developer, not only a device software vendor. Our engineers take products from concept and sensor selection through prototyping, embedded firmware, diagnostic algorithms, verification testing and regulatory submission. Everything is produced inside a design-controlled SDLC under IEC 62304, ISO 13485 and ISO 14971, so the design history file grows with the product instead of being reconstructed before filing.

What's included

Core capabilities

01

Device Design & Prototyping

Concept, sensor architecture, industrial design and bench prototypes for monitoring and point-of-care diagnostics.

02

Firmware & Diagnostic Algorithms

Real-time safety-critical firmware plus proprietary SaMD models that turn raw signal into clinical findings.

03

Clearance & Clinical Evidence

Verification, validation, human factors and 510(k) / CE-MDR documentation prepared in-house.

Let's talk

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