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Device Design & Prototyping
Sensor architecture, industrial design and bench prototypes for monitoring and point-of-care diagnostics.
All expertise
Expertise
Medical Device Development
Devices We Design, Build and Take to Clearance
EldoNova+ develops its own connected medical devices. From sensor architecture and prototype hardware to embedded firmware, diagnostic algorithms and submission dossiers, we build the instruments that improve care — and bring that same discipline to partner device programs.
Contact UsWhat we offer
Tailored medical device development services
We treat regulatory rigor as an engineering discipline. Requirements, risk analysis, architecture, verification and traceability are produced continuously as the device is built, so the design history file is always current and audit-ready — whether the product is ours or yours.
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Embedded & RTOS Firmware
Deterministic firmware for diagnostic, monitoring and therapeutic devices.
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Software as a Medical Device
Class I-III SaMD and proprietary diagnostic algorithms with risk controls and clinical evaluation.
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Device-to-Cloud Telemetry
Fleet monitoring, OTA updates and high-volume ingestion pipelines.
Why EldoNova+
Built by specialists who ship
We Build Our Own
A development partner that has taken its own devices through design controls and verification.
Regulatory-Native Teams
Engineers, QA and regulatory specialists working from the same backlog.
Traceability by Default
Requirement-to-test traceability generated from tooling, not spreadsheets.
Cybersecurity Built In
Threat modeling and SBOMs aligned to FDA premarket cybersecurity guidance.
Benefits
Outcomes you can measure
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Faster Clearance
Submission-ready documentation shortens 510(k) and CE-MDR timelines.
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Lower Risk
ISO 14971 risk management woven into every sprint.
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Longer Device Life
OTA updates and telemetry keep fielded devices safe and improving.
Where this shines
- Wearable ECG and continuous monitoring patches
- Infusion and drug-delivery device controllers
- Imaging and diagnostic workstation software
- Connected home-based therapy devices
Explore more expertise
HL7 Interface & Integration
Custom HL7 integrations that connect labs, radiology, and EMRs into a single, secure data fabric.
Learn moreIntegrated Telehealth Solutions
HIPAA-compliant telehealth platforms with video visits, e-prescribing, and EMR-native workflows.
Learn moreMedical Billing Software
End-to-end revenue cycle software — eligibility, claims, denials, and analytics in one place.
Learn moreLet's talk
Ready to Start Your Journey?
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New York, NY