Installation & IQ/OQ/PQ
Validated commissioning under 21 CFR 820 and ISO 13485:2016 design controls for laboratory and care-setting installs.
Service & Support
Service tiers document uptime targets, mean-time-to-repair windows, and OEM parts coverage by contract — values are confirmed in the facility-specific service schedule, not as a universal website claim.
Validated commissioning under 21 CFR 820 and ISO 13485:2016 design controls for laboratory and care-setting installs.
OEM-recommended PM schedule with documented 21 CFR Part 11 traceability and NIST-traceable calibration.
24/7 dispatch · Tier 1-3 escalation · cybersecurity patch deployment · loaner units during repair windows.
Power, HVAC, RF shielding, and EMC requirements verified against IEC 60601-1-2.
Installation, Operational, and Performance Qualification documented for audit packs.
Superuser certification covering operator competency and reprocessing interfaces.
Quarterly PM, calibration certificates, and firmware/security patch cadence.
UDI deregistration, NIST SP 800-88 media wipe, and recycling certificate.
We benchmark uptime, PM compliance, and EOL exposure against Draeger reference hospitals of similar bed count and laboratory volume.