Platform

Every device in the field, one view

Build a device fleet management solution that connects each serial number to the data it produces. Extra Horizon provides flexible tools to define the registry, workflows and views around your specific needs.

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Medical device fleet management dashboard with device registry, firmware versions and rollout status

Devices in the field

Shipping the device was the easy part

The day your device is certified, the fleet becomes the product. Thousands of wearables, analysers and gateways in homes and hospitals — each with its own firmware version, battery state and service history.

Which firmware runs where?

Once devices leave the warehouse, versions drift. A recall or CAPA starts with one question — which serial numbers are affected — and answering it from spreadsheets takes days.

Is the device a patient depends on still working?

A silent device can mean an empty battery, a lost connection or a missed measurement. You want to know before the patient calls support, not after.

Can you prove it when the auditor asks?

Post-market surveillance and cybersecurity obligations expect you to know the state of your fleet and show its history. Evidence assembled by hand doesn't survive scale.

Fleet management

Build a registry for everything you've shipped

Fleet management on Extra Horizon is not a separate, fixed tool. Use flexible data models and workflows alongside your users, data and clinical workflows to build the fleet experience your product requires.

Device registry

Build and control a data model for every device you've shipped — including UDI, serial number, model and current owner.

Device status

Model the connectivity, battery and error states that matter to your devices, then make them available to your support team.

Firmware tracking and rollouts

Build the version tracking and staged rollout workflows your fleet requires, including adoption monitoring and rollback logic.

Cohorts and grouping

Create the groups and filters that fit your fleet — by model, market, hospital, study arm or any criteria you define.

Calibration and consumables

Model calibration due dates, service intervals and consumable state, then create workflows to plan interventions.

Audit-ready history

Define the registrations, updates and state changes you need to record, and build a traceable history for audits.

Built for regulated devices

Field evidence your QA team can inherit

Your notified body doesn't care how elegant the dashboard is — it cares whether you can demonstrate control over devices in the field. That is what this is built around.

MDR post-market surveillance

Structured field data feeds your PMS reports and PSURs directly, instead of another quarter of manual exports.

Cybersecurity updates

FDA section 524B and IEC 81001-5-1 expect patchable devices and update evidence. Staged rollouts give you a record of who got what, and when.

A qualified supplier

The platform underneath is ISO 13485, ISO 27001 and IEC 62304 certified and slots into your supplier controls — evidence you inherit, not produce.

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Customer cases

What our customers say

ABCDx
In Vitro Diagnostics
"This partnership with Extra Horizon marks a significant milestone in our journey towards transforming stroke diagnostics. LVOCheck represents not just an innovation in technology, but a step forward in making advanced healthcare accessible and efficient."
Jean-Charles Sanchez

Jean-Charles Sanchez

CEO, ABCDx

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ams AG
In Vitro Diagnostics
"Extra Horizon offers best-in-class medical cloud solutions through their deeply proven expertise in medical cloud. The company's professional expertise in developing customized solutions, leveraging an extensive backbone knowledge, makes it an ideal partner for this important undertaking."
Pierre Laboisse

Pierre Laboisse

Executive Vice President Global Sales and Marketing, ams AG

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FibriCheck
Software as a Medical Device
"The Extra Horizon platform has played a key role in helping FibriCheck meet the strict compliance issues that apply to medical software and has allowed FibriCheck to stay ahead of the curve."
Lars Grieten

Lars Grieten

CEO, Founder, FibriCheck

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Let's talk about your device fleet!

Get in touch, explain what you want to build, or have us help you build, and we'll get back to you ASAP! →