Connected implantable devices patients depend on? We’ve done them.
Secure wireless, reliable device-to-device links, fleet management and accurate sensing for wearables, monitors, implant programmers and home-care equipment.
A reliable link is only the start. Trust has to be designed in.
A connected medical device has to pair with the right phone, hub or companion device every time, protect patient data on every link, keep running on a small battery and still measure accurately in a noisy hospital or home.
Regulators now expect cybersecurity designed in from the start, with a threat model, a software bill of materials and a plan for updates. We build the hardware, firmware and connectivity with that evidence in mind, so security isn’t a retrofit before submission.
Everything a connected medical device needs.
Security by design
Per-device identity, secure boot, encrypted storage and authenticated links, with the threat model and SBOM to show for it.
Device-to-device communication
Sensors, patches, pumps, hubs and phones that pair once and stay connected, over Bluetooth LE, Wi-Fi, cellular or proprietary radios.
Device management
Provisioning, signed over-the-air updates, crash reports and fleet health, so you can patch fast and prove what’s in the field.
Accurate sensing
Biosignal, temperature, motion and pressure front ends designed for low noise and stable readings on the body and at the bedside.
Days, weeks or years on a battery
Low-power hardware and firmware for wearables and disposables that can’t be charged every night.
Ready for your submission
Design records, test evidence and documentation that support your quality system and your regulatory team.
RELIABILITY AND COMPLIANCE
Reliable on the bench. Ready for your regulatory team.
A medical device has to work every time, and you have to show the evidence. We design for reliability from the first schematic and produce the engineering records your quality and regulatory teams build on.
Recovers on its own
Watchdogs, safe states, brown-out handling and updates that roll back cleanly if power drops halfway.
Holds the link
Reconnection, retries and coexistence tested against hospital Wi-Fi and a crowded 2.4 GHz band.
Proven, not assumed
Unit, integration, hardware-in-the-loop and environmental tests, with every result traced to a requirement.
Electrical safety and EMC
Isolation, leakage and emissions designed in from the schematic, with pre-compliance scans before the test lab.
Software life cycle
Firmware built with documented requirements, architecture, unit verification and traceability matched to your software safety class.
Quality management
We work inside your design controls and deliver design inputs, reviews and verification records in your formats.
Risk management
Hazard and failure-mode analysis for the radio, power and firmware, with each risk control implemented and verified.
Cybersecurity for your submission
Threat model, SBOM, security architecture views and test results, plus the plan for patching devices in the field.
Technical documentation
Engineering evidence for Annex I safety and performance requirements, including the cybersecurity guidance in MDCG 2019-16.
Our components are tested and validated for Class C operation. We support your compliance work with design, testing and documentation. Certification, clearance and the regulatory strategy stay with you, your notified body and your regulatory team.
Advanced technology we build ourselves.
OUR TECHNOLOGY
BlueNox™
Bluetooth Classic, LE and LE Audio with custom authentication, so only approved apps and devices connect.
Explore BlueNox™ →
OUR TECHNOLOGY
NoxTLS™
TLS 1.3 and crypto small enough for the microcontroller inside the device.
Explore NoxTLS™ →
OUR TECHNOLOGY
FleetNox
Provisioning and signed updates for every device in the field.
Explore FleetNox →
Where we help.
Wearables and patches
Continuous monitoring that streams to a phone or hub without draining the battery.
Monitors and diagnostics
Bedside and point-of-care equipment that shares data securely with hospital systems.
Companion apps
iOS and Android apps that pair reliably and only talk to genuine devices.
Home care
Connected devices patients set up themselves, with remote management for your team.
Common questions
Can you work inside our quality system?
Yes. We follow your design controls and deliver the records your process requires, from requirements and risk analysis to verification evidence.
Can you help with cybersecurity documentation?
We produce the engineering evidence behind it: threat models, a software bill of materials, security test results and an update plan your regulatory team can build on.
Can you fix connectivity on a device that’s already on the market?
Yes. We find the cause of dropouts, pairing failures or range problems and change only what needs to change, keeping the impact on your existing clearance as small as possible.
Building a connected medical device?
Tell us where you are, from first concept to a product in the field.
