Clinical service methodology
ISO 13485:2016 service procedures · IEC 60601-1 preventive maintenance intervals · NIST-traceable calibration on every contracted visit. Scope remains reference-specific and market-specific.
Coverage specification
Coverage labels are not universal promises. The signed statement of work should record supported assets, geography, hours, exclusions, escalation, and documentation for each site.
| Service Tier | Coverage | On-site Response | Documentation |
|---|---|---|---|
| Platinum 24/7 | 365d × 24h, listed fault classes for sterilizers, washers, and critical monitors | ≤ 4h urban planning window where contracted | IQ/OQ/PQ package + 21 CFR Part 11 audit trail where applicable |
| Gold | Mon–Sun 07:00–19:00 | ≤ 8h planning window | OQ/PQ + signed service report |
| Silver | Mon–Fri 08:00–17:00 | Next-business-day parts shipping where contracted | PM compliance log |
| Per-Call | On demand | 24–72h after asset and access review | Service report only |
Repeatable handoff
List device references, critical accessories, calibrated tools, operator roles, complaint routing, design history file (DHF) dependencies, device master record (DMR) controls, and the boundary between Getinge, distributor, hospital biomed, dental practice, and quality teams.
Review qualification records, replacement-part identity, UDI and lot traceability, software compatibility, and evidence required before a serviced sterilizer, washer, dental unit, or monitor returns to clinical use.
IEC 62304 lifecycle evidence, SBOM status, cybersecurity advisories, firmware compatibility, rollback planning, and data-integrity checks are documented apart from mechanical preventive maintenance.
Record test environment, simulator or biological indicator method, measured result, essential performance, electromagnetic compatibility (EMC) conditions, acceptance criterion, deviations, approver, and timestamp.
Prepare the review
Include asset family, facility type, operating hours, market, interface ownership, and the evidence your quality team must retain.
Scope a service review