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The medical-device, biomedical-engineering and compliance backbone for healthcare
Hospital networks, primary-care clinics and pharma manufacturers run thousands of regulated medical devices, critical IT systems and cold-chain biologics against a dense regulatory web. Osolix is the fixed-asset register, maintenance engine and compliance evidence layer that keeps every device audit-defensible.
Primary solutions
Killer workflows
Built for the real-life flows a biomedical-engineering and compliance team runs every day.
Medical-device register
Per-device tracking with FDA UDI / EU UDI / DHA registration, 510(k) clearance and MDR conformity evidence, and Class I/II/III risk classification on every unit.
Calibration certificate management
Annual, biannual or pre-procedure calibration cycles with certificate traceability to an ISO 17025-accredited lab. Overdue devices are auto-flagged and blocked from clinical use.
Biomedical work orders
Offline-capable field-engineering mobile work orders, parts-pull from the dedicated biomedical-engineering store, and vendor service-contract tracking per device.
Cold-chain biologic inventory
Continuous temperature logging for vaccines, blood, tissue and biologics. Excursion alerts auto-quarantine out-of-spec batches and preserve chain-of-custody.
Patient-data-linked asset register
Devices that store or process patient data are flagged for HIPAA scope, carry an IEC 80001 network-segmentation requirement, and track an annual security pen-test.
OR + ICU compliance
Per-room asset register with the equipment each accreditation standard requires, plus pre-procedure readiness checks (autoclave OK? defib charged? ventilator pre-test passed?).
Standards in scope
Every device decision maps to the standard it must satisfy — across the US, EU, UK and GCC.
Why teams switch to Osolix
The FAR + medical-device + biomedical-engineering + compliance backbone for hospitals, clinics and pharma.
Heavy ServiceNow lock-in — Osolix is platform-independent and cheaper.
Service-bureau model — Osolix is software-only and customer-owned.
Clinical-data analytics only — Osolix is the FAR + maintenance backbone.
Osolix wins on healthcare-specific depth: UDI, calibration, MDR.
See Osolix run your medical-device register
Start a free trial and import your device register, or open the in-app Healthcare hub to explore the UDI registry and calibration workflows live.