Installation & IQ/OQ/PQ
Validated commissioning under 21 CFR 820 and ISO 13485:2016 design controls, including site readiness, acceptance criteria, and signed handover documentation.
Service & Support
Draeger service programs are designed for clinical environments where uptime, documentation, and escalation discipline are as important as device performance. Our support model gives biomedical teams a clear path from site planning to commissioning, from preventive maintenance to recall response, and from operator training to end-of-life decommissioning. Each engagement starts by defining the installed-base risk profile: facility type, asset criticality, maintenance history, software exposure, spare part availability, and operational impact if a device falls out of service.
Validated commissioning under 21 CFR 820 and ISO 13485:2016 design controls, including site readiness, acceptance criteria, and signed handover documentation.
OEM-recommended PM schedules with calibration evidence, software status notes, safety checks, and audit-ready service reports for CMMS attachment.
24/7 dispatch, Tier 1-3 escalation, loaner coordination, and parts staging for critical care, laboratory, infection-control, and home-care portfolios.
Power, HVAC, network, storage, decontamination, and user access requirements are checked before equipment arrival so installation does not become a clinical disruption.
Installation Qualification, Operational Qualification, and Performance Qualification records are packaged with acceptance criteria and device configuration notes.
Superuser instruction covers IFU interpretation, alarm response, specimen handling, consumable storage, and caregiver teach-back where home deployment is involved.
Scheduled visits document calibration, software status, cybersecurity advisories, service history, and CAPA triggers if repeat faults appear.
Data handling, UDI retirement, recycling certificates, consumable phaseout, and replacement planning are handled as controlled tasks.
We will benchmark uptime, PM compliance, software exposure, consumable continuity, and end-of-life risk against facilities with comparable care settings. The result is a pragmatic service plan that procurement can cost, biomed can govern, and clinical leadership can understand.