Services
SVH Platform Integration
The SVH Zero Trust Device Operations Platform gives a connected medical device a cryptographic identity, a managed lifecycle, and a trusted path for its data. We do the device-side work to get yours on it: the SVH Device Agent integrated into your device software, identity and secure updates wired in, and clinical data flowing out in the standards hospitals accept.
The problem
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Hospital customers now ask how your device proves what it is, what firmware it runs, and how it gets patched — and "it has an API" has stopped being an acceptable answer.
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Your device team is a hardware and firmware team. Certificates, mutual TLS, over-the-air updates, and HL7v2/FHIR output are a second product nobody budgeted for.
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The FDA premarket cybersecurity file needs an SBOM, a threat model, and a credible update story — for a device that is already shipping.
How we work
- 01
Device assessment
We review your device platform — SoC, OS or RTOS, memory, radios, build system — and map how the SVH Device Agent fits it, what has to change, and what can stay.
- 02
Agent integration
The SVH Device Agent is embedded-Linux native; we integrate it into your Yocto build or firmware, with gateway-side integration for devices that cannot host it.
- 03
Identity, updates & data
Per-device X.509 identity and mTLS, signed A/B updates with rollback, and device telemetry and clinical data mapped to HL7v2, FHIR, or MQTT.
- 04
Verification & handover
End-to-end verification against an SVH server, cybersecurity evidence for your submission, and your engineers trained to own the integration going forward.
What you get
- A device integration architecture document your RA/QA and security reviewers can read before anything ships
- SVH Device Agent integrated and verified on your target device platforms
- Per-device certificate identity, mutual TLS, and secure provisioning at manufacture
- Signed over-the-air update path with tested rollback
- Device data published in HL7v2, FHIR R4, or MQTT, verified end to end
- SBOM, threat-model inputs, and update documentation designed to support FDA premarket cybersecurity expectations
Standards & technologies
- SVH Device Agent
- Embedded Linux
- Yocto / OpenEmbedded
- X.509 / mTLS
- RAUC / SWUpdate
- HL7v2
- FHIR R4
- MQTT
- IEC 62304
- IEC 81001-5-1
New to the platform? The SVH Zero Trust Device Operations Platform — device agent, management server, and fleet operations for connected medical devices — is described at svhplatform.com →
Why an integration partner matters
Direct line to the platform team
When your device hits an edge case in the agent, we don't file a support ticket — we talk to the people who wrote it. Escalations are conversations, not queues.
Device engineers, not platform salespeople
The team integrating the agent builds Yocto images, bring-up boards, and signs firmware for a living. Your device constraints are our normal working conditions.
Device feedback shapes the platform
Integration friction we hit on your device feeds the platform roadmap — what hurts once tends to disappear in the next agent release.
Common questions
Which devices can run the SVH Device Agent?
Any device with an embedded Linux footprint — infusion pumps, patient monitors, imaging and lab systems, ventilators, and the gateways in front of them. Microcontroller-class devices are integrated through a gateway that carries the agent on their behalf.
Our firmware is built by a contract manufacturer or vendor. Can you still integrate?
Yes. We work with whoever owns the build — your team, your ODM, or your SoM vendor — and deliver the integration as a layer they can carry forward.
Does the device have to run Linux?
The agent does. If the device itself runs an RTOS or bare metal, we integrate at a Linux gateway or companion module and the device enrolls through it.
How does this help our regulatory submission?
The integration produces the artifacts cybersecurity reviewers ask for — SBOM, update mechanism, identity and authentication design — and our practices are designed to support IEC 62304 and FDA premarket cybersecurity guidance. Regulatory strategy stays with your RA/QA team.
Ready to make your device SVH-native?
Bring us a device, an integration problem, or a product idea — we will come back with an approach, not a slide deck.