Predictive Maintenance
Device telemetry trends flag reagent fluidics, centrifuge imbalance, and autoclave vacuum faults 7–14 days ahead of typical hard failures.
Telemetry-aware field support for analyzers, sterilizers, and dental imaging. Cybersecurity patches and SBOM updates aligned with FDA Premarket Cybersecurity Guidance (2023) and IEC 62304 lifecycle controls.
Device telemetry trends flag reagent fluidics, centrifuge imbalance, and autoclave vacuum faults 7–14 days ahead of typical hard failures.
Controlled OTA packages under change control with IEC 62304 traceability and release notes tied to UDI configuration.
SBOM scan cadence, coordinated vulnerability disclosure, and NIST CSF-aligned patch windows for networked IVD and imaging nodes.
ORM/ORU and FHIR R4 result exchange for LIS; DICOM for dental CBCT and selected imaging peripherals without opaque middleware claims.
KPI dashboards for lab TAT, CSSD load utilization, and dental operatory turnover using site-owned data only.
Device sunset playbook with UDI deregistration, data export, and parts harvesting documented for asset disposal.
Service metrics are planning examples for contracted portfolios, not audited global uptime or installed-base claims. Confirm SLA language in the service agreement for your site and market.