Installation & IQ/OQ/PQ
Validated commissioning under 21 CFR 820 and ISO 13485:2016 design controls, including network hardening and identity provisioning.
Service engineered for installed base
Uptime and response targets are contract-tier fields—not website guarantees. Tier-1 hospital agreements typically define measured availability, MTTR windows, and parts pre-positioning against the installed SKU list and region.
Validated commissioning under 21 CFR 820 and ISO 13485:2016 design controls, including network hardening and identity provisioning.
OEM-recommended PM schedule with NIST-traceable calibration and 21 CFR Part 11–ready audit trails where applicable.
24/7 dispatch · Tier 1–3 escalation · OEM parts inventory across Siemens Healthineers regional hubs.
Lifecycle process
Power, HVAC, RF shielding, and network requirements verified against IEC 60601-1-2 EMC.
Installation, Operational, and Performance Qualification documented for biomedical release.
Superuser certification covering alarm protocols, transport workflows, and cybersecurity hygiene.
Scheduled PM, NIST-traceable calibration, firmware and cybersecurity patch deployment.
UDI deregistration, IT asset wipe (NIST SP 800-88), and recycling certificate.
We benchmark uptime, PM compliance, alarm configuration drift, and end-of-life exposure against hospitals of similar bed count—using your CMMS baseline, not a published universal SLA.