Installation & Commissioning
Site readiness, electrical compatibility, inventory receipt, asset tagging, acceptance checks, and configuration records.
SERVICE & SUPPORT PATHWAY
Keep procedure support visible from evaluation to retirement
Define ownership for commissioning, training, preventive maintenance, complaint intake, field action, and end-of-life disposition before adoption.
Preventive Maintenance
Document the OEM interval, test method, calibrated equipment, pass criteria, software baseline, and next due date.
Field Service & Repair
Capture symptoms, error state, affected accessories, patient impact, serial or UDI information, and safe isolation status.
FIVE CONTROLLED HANDOFFS
A lifecycle that the clinical and biomed teams can audit
- 01
Site assessment
Map power, environmental, network, room-layout, storage, and reprocessing dependencies.
- 02
Acceptance & baseline
Record received configuration, inspection results, accessories, software, and service contacts.
- 03
Clinical training
Use role-specific competency checks for setup, activation, alarms, shutdown, and escalation.
- 04
Maintenance & surveillance
Track PM completion, repair history, complaints, field notices, and local CAPA decisions.
- 05
Decommissioning
Remove patient data where relevant, reconcile assets, document disposal, and retain required records.
4 fieldsserial/UDI, symptom, impact, safe state
1 ownerassigned to every open action
2 clocksclinical urgency and service response
0 guessworkcurrent IFU governs handling
SERVICE AUDIT INTAKE
Map the installed-base gap before writing the SLA
Provide facility type, approximate asset count, service geography, current PM completion rate, and your most costly downtime mode.
- Separate critical-response targets from routine scheduling
- Identify loaner, parts, and training dependencies
- Set evidence and escalation records before go-live