Medical devices / IVD devices
Every analyzer connected to the lab, securely
For IVD device makers. Give your instruments a verified identity, deliver every result to the LIS and EHR, and keep patient data sealed from device to destination. Under your brand.
A fleet console in the device maker's brand: devices online, an update rolling out in waves and a live heartbeat.
- Results over HL7 v2, ASTM, POCT1-A2 and FHIR
- Patient data sealed from device to LIS
- Analyzers in the field connect unchanged
- Designed to support IEC 62304 and 81001-5-1
Where it runs
New analyzers run the agent. Analyzers already in the field connect through the bridge. Both reach the lab through one Fleet Server in the hospital.
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Partner back office, run by SVH
SVH Partner Portallicenses, birth certificates, signingYou, the device makerrequest licenses, release updatessigned bundle, applied offline · no live link from the portal
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At the point of care and in the lab
New analyzersblood gas, point of careSVH Device Agenthardware identity · offline queue · signed updates · sandboxmutual TLS to the Fleet Server
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Hospital network
Analyzers in the fieldunchanged firmware · ASTM · POCT1-A2 · HL7 v2SVH Device Bridgetranslates their protocol · relays closed networksmutual TLS to the Fleet Server
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SVH Fleet Server · on premises, your cloud or hosted by SVH
SVH Fleet ServerResults and delivery tracking · QC, calibration, autoverification · Lots, consumables, orders · consoles in your brand -
Hospital systems
LISHL7 v2 · ASTM: results out, orders inEHR / HISFHIR R4 · HL7 v2Lab staff and ITsingle sign-on, badge at instrument
- At the point of care
- New analyzers run the agent: hardware identity, an offline queue and signed updates.
- Hospital network
- Analyzers in the field connect through the bridge over ASTM, POCT1-A2 or HL7 v2, firmware unchanged.
- SVH Fleet Server
- Results, QC, lots and consumables, delivered to the LIS and EHR. Patient data stays in the hospital on premises.
- Partner back office
- The SVH Partner Portal issues licenses and certificates. It has no live link to any hospital.
The life of one result
A blood gas result, from the moment it is measured to the moment the LIS confirms it. Nothing in between can read it, lose it or reorder it.
- Measured The analyzer finishes the run. On the device
- Sealed Patient data is encrypted before it leaves the app. Agent
- Queued Stored durably. Network down? It waits, in order. Agent
- Delivered Over mutual TLS, acknowledged end to end. Agent to Fleet Server
- Checked QC rules, delta checks and autoverification. Fleet Server
- Sent To the LIS and EHR in their own standard. Fleet Server
- Confirmed When it was sent and acknowledged, on record. Audit trail
What the medical layer adds
Everything in the core platform, plus the workflows a lab expects from a connected instrument.
Results and orders
- Results, QC and calibration runs to the LIS
- Orders, worklists and host query back in
- Patient and MRN matching
- Delivery tracking per result
- Several LIS and EHR connections at once
Quality and consumables
- QC with Westgard rules
- Autoverification and delta checks
- Lot, expiry and calibration state
- Recall by lot, stock on hand
- A "can it run?" readiness view
At the instrument
- Operator sign-in by badge or PIN, even offline
- Operator lists and lockout from the Fleet Server
- Analyte menus and settings synced to devices
- Signed firmware updates the lab can schedule
- Acute care today: blood gas, electrolytes, cardiac markers
Standards the lab already uses
Your firmware doesn't need to speak any of them. The Fleet Server and bridge do.
| To LIS and EHR | FHIR® R4, HL7® v2.x over MLLP, ASTM E1394 / LIS2-A2, JSON webhooks |
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| From analyzers without an agent | ASTM E1381 / E1394, POCT1-A2, HL7® v2 over MLLP, through the SVH Device Bridge |
| Coding | LOINC®, UCUM, SNOMED CT® |
| Sign-in | LDAP or OIDC single sign-on; badge or PIN at the instrument, offline |
Regulatory posture, sealed patient data and the evidence in every release are on the Medical devices page.
Questions IVD teams ask
Do we have to add HL7 or FHIR to our firmware?
No. Your instrument talks to the SVH Device Agent or the bridge. The Fleet Server handles HL7, FHIR and ASTM toward the LIS and EHR.
Can we connect analyzers already installed at customer sites?
Yes. The SVH Device Bridge connects them over ASTM, POCT1-A2 or HL7 v2, with a driver profile per model and no firmware change.
Which disciplines are supported?
Acute care today: blood gas, electrolytes and cardiac markers, plus consumable and QC tracking. Tell us your discipline on the device check and we'll tell you where it stands.
Can SVH connect your analyzer?
Answer six short questions. Within two business days we reply with the path for your device. Then we book a demo with your engineers.