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SVHSoftware

Industries / Medical devices

Medical devices your customers can trust on the network

For medical device makers. Give every instrument, monitor and pump a verified identity, signed updates and sealed patient data, with the evidence a regulated product needs. Under your brand.

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A fleet console in the device maker's brand: devices online, an update rolling out in waves and a live heartbeat.

Where it runs

Four products, each with one place to run. Your customers see your brand on every screen; SVH stays behind it.

  1. Partner back office, run by SVH

    SVH Partner Portallicenses, birth certificates, signing
    You, the device makerrequest licenses, release updates

    signed bundle, applied offline · no live link from the portal

  2. In your device

    Your device appnever touches the network
    SVH Device Agenthardware identity · offline queue · signed updates · sandbox

    mutual TLS to the Fleet Server

  3. On the site network

    Devices already in the fieldno agent, no firmware change · ASTM · HL7 · POCT1 · MQTT
    SVH Device Bridgetranslates their protocol · relays closed networks

    mutual TLS to the Fleet Server

  4. SVH Fleet Server · on premises, your cloud or hosted by SVH

    SVH Fleet ServerFleet, certificates, device twins · Updates, configuration, licensing · Data pipeline and audit · consoles in your brand

  5. Your customer's systems

    Business and clinical systemswebhooks · FHIR · HL7
    Your own appsopen REST APIs
    Admins and operatorssingle sign-on
In your device
The SVH Device Agent gives it an identity, queues data offline and applies signed updates.
On the site network
The SVH Device Bridge connects devices that run no agent, in the protocol they already speak.
SVH Fleet Server
One per customer site. Fleet, updates, data and integrations, with consoles in your brand.
Partner back office
The SVH Partner Portal issues licenses and certificates. It reaches sites only through signed bundles applied offline.

Device types

The core platform works the same for every medical device. IVD has its own layer of clinical workflows today.

IVD devices

Analyzers, point-of-care testers and home-use diagnostics: every device that tests a sample. Results to the LIS and EHR over FHIR, HL7 v2, ASTM and POCT1-A2, QC with Westgard rules, lots and consumables, and operator sign-in at the instrument. Acute care today: blood gas, electrolytes and cardiac markers.

See the IVD page
Patient monitors and vital-signs devices
Bedside, transport and wearable monitors
Infusion and therapy devices
Pumps, ventilators, dialysis and respiratory equipment
Home and remote monitoring devices
Wearables, telehealth kits, remote patient monitoring
Imaging accessories and workstations
Injectors, positioning systems, review stations
Surgical and clinical equipment
Towers, tables, sterilization and tracking systems

Connected through the core platform: identity, signed updates, sealed data and consoles in your brand. Clinical workflows and interfaces for these devices are scoped with you on the first call.

Patient data stays sealed

Patient data is encrypted on the device and opened only where it is needed. The platform moves it without reading it, and analytics never see who the patient is.

Every access to patient data is written to a tamper-evident audit trail you can export.

Patient data is sealed on the device, cannot be read on the network or gateways, and is opened only at the clinical record. Analytics receive de-identified data. Device Clinical record network and gateways sealed: cannot be read in transit Analytics de-identified by design Patient identity is kept separate from analytics and device telemetry.

Built for regulated products

The evidence your submission and your customers' security reviews ask for comes with the platform.

Evidence in every release

  • CycloneDX SBOM served from a live endpoint
  • Security documentation for your technical file
  • Signed images and modules, verified before they run
  • Tamper-evident audit trail you can export

Designed to support

  • IEC 62304 software lifecycle
  • IEC 81001-5-1 secure development
  • FDA premarket cybersecurity guidance (2023)
  • HIPAA and GDPR

Where it runs

  • On premises: patient data stays in the hospital
  • Your cloud: patient data sealed end to end on its way
  • Hosted by SVH: operated for you
  • An installation can move between them

SVH is designed to support your security and compliance programs. It does not by itself constitute certification or regulatory clearance. The full posture is on the Security page.

Questions medical device teams ask

Which medical devices does SVH support?

The core platform is the same for every device: identity, signed updates, sealed data delivery and consoles in your brand. The medical layer that has shipped is for IVD: results to the LIS and EHR, QC, lots and consumables. Workflows for other device types are scoped with you on the first call.

Does patient data leave the hospital?

Not with an on-premises installation: patient data stays on the Fleet Server in the hospital. With a cloud installation, patient data is sealed end to end on its way there.

Will this help our regulatory submission?

SVH is designed to support IEC 62304, IEC 81001-5-1 and FDA premarket cybersecurity guidance: SBOM, secure update with rollback, attestation and audit come built in. It does not by itself constitute regulatory approval.

Is SVH itself a medical device?

SVH Platform is software your device and your customers use; it does not by itself constitute regulatory approval, and your product's classification stays with you. We provide the SBOM, security documentation and audit evidence your submission draws on.

Can SVH connect your device?

Answer six short questions. Within two business days we reply with the path for your device. Then we book a demo with your engineers.

Tell us about your instrument.

Check my device

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