You own the regulatory file. We build the software.
Embedded, companion app, and device-to-cloud engineering for connected medical devices. We support your engineering evidence and delivery. We do not replace your quality system, and we will tell you so on the first call.
Scoped by sprint against an hour range with a hard ceiling
10+ years average experience
You own every line in your GitHub org
You retain regulatory ownership, always
Published rates. Hour ceilings in writing.
Connected-Device Architecture Review
$150 /hour
Trust boundaries across firmware, transport, client, and cloud
Direct Slack and US-hours overlap
Billed every two weeks
Embedded & Companion App Delivery
$150 /hour
Firmware, device interfaces, and the app that talks to them
Secure OTA update designed as a safety-critical capability
SBOM and fleet-security telemetry for fielded devices
Commercial Terms, in Writing
Billed every 2 weeks: pay only for developer man-hours
Written sprint range with a hard ceiling
Estimates and clarification meetings are free
Direct access to the engineers doing the work
Choose on-demand capacity or a larger team. Every sprint has a written hour range and a hard ceiling.
Where our lane ends.
Our device experience is industrial. MK Products is an ISO-certified manufacturer and our scope there spans Android, embedded, USB, kiosk and device debugging. That is not medical-device work, a safety outcome, or evidence of regulatory compliance, and we will not present it as any of those.
“Horizon's Gorkem Bendin understands the tradeoffs required for real-time embedded processing and is able to write Android code that partitions the expensive computations outside the fast loops and allows our code to offer timely information to the users of our product. Highly recommended.”
Andrew Ward · Engineering Manager, MK Products
“Horizon Labs vastly increased our visibility into technical workflows and capacity to achieve projected outcomes. They have a fast and reliable team with exceptional integrity.”
Marcus Ellison · CEO, TrueChoice
60+ products shipped
Since 2019. Healthcare systems experience from a national health portal, Tasso Health and Oscar Health: software and infrastructure, not regulated devices.
Deliverables written to slot into your design history file
Bounded, documented scope; code lands in your repo
Working knowledge of IEC 62304, ISO 13485 and ISO 14971
Handled in the contract.
“You've never shipped a cleared device.”
Correct, and we lead with it. What we bring is senior embedded and connected-systems engineering, plus a published working knowledge of the standards your file has to satisfy. You keep the submission.
“An outside team will contaminate our design controls.”
Scope is bounded and documented, code lands in your repo, and the deliverable is written to slot into your existing design history file rather than sit beside it.
“We can't afford a learning curve on IEC 62304.”
You aren't paying for one. Read our compliance glossary covering IEC 62304, ISO 13485, ISO 14971, the FDA QMSR and Section 524B before the call, and judge for yourself.