Installation & IQ/OQ/PQ
Validated commissioning under 21 CFR 820 and ISO 13485:2016 design controls, including RF shielding, HVAC, and power verification for CT/MRI rooms.
Service & Support
99.5% uptime SLA planning across Globus Medical imaging installed base. Mean-time-to-repair under 6 working hours for Tier-1 hospital sites with OEM parts staging.
Validated commissioning under 21 CFR 820 and ISO 13485:2016 design controls, including RF shielding, HVAC, and power verification for CT/MRI rooms.
OEM-recommended PM schedule with NIST-traceable calibration, tube warm-up logs, and 21 CFR Part 11 style electronic records where configured.
24/7 dispatch · Tier 1–3 escalation · OEM parts inventory across Globus Medical regional hubs with loaner coverage for major outages.
Lifecycle path
Power, HVAC, RF shielding, and lead-line requirements verified against IEC 60601-1-2 EMC.
Installation, Operational, and Performance Qualification documented for biomed and physics sign-off.
Superuser certification covering protocol libraries, dose dashboards, and DICOM routing drills.
Quarterly PM, tube/coil checks, cybersecurity patch deployment with SBOM updates.
UDI deregistration, IT asset wipe (NIST SP 800-88), and recycling certificate.
Planning figures above apply to contracted Tier-1 urban sites with OEM parts staging. Rural, multi-vendor rooms, or expired software support may exceed MTTR / uptime targets. Parts inventory value is a network planning figure, not a site-level promise.
We benchmark uptime, PM compliance, tube-hour exposure, cybersecurity patch lag, and EOL risk against Globus Medical reference hospitals of similar modality mix and bed count. Audit outputs include IQ/OQ/PQ gap lists and SBOM currency—not clinical outcome guarantees.