24/7 FSE Hotline +1-800-GETINGE | [email protected] EN | ES | FR-CA
Service & Support

Service Engineered to Your QMS

Getinge organizes service for sterilizers, washer disinfectors, patient monitoring workflows, infection control supplies, and dental or oral health equipment as a documented operating system. Each engagement begins with the care setting, intended use, installed base age, cleaning pathway, service tier, cybersecurity responsibility, and documentation package expected by the value analysis committee. The result is a service plan that biomedical engineering can audit, procurement can compare, and clinical managers can explain without rewriting the supplier record.

Structured Coverage

Service tiers with response, records, and ownership defined

For large hospital systems, a service promise is useful only when the coverage window, spare-parts routing, and evidence file are visible before purchase. Getinge maps each tier to ISO 13485 service procedures, preventive maintenance intervals, signed work orders, and escalation responsibilities, so internal teams can align uptime targets with capital budget and operating risk.

Service TierCoverageOn-site ResponseDocumentation
Platinum 24/7365 days x 24 hours, all fault classes4 hour urban targetIQ/OQ/PQ, PM certificate, service audit trail
GoldMon-Sun 07:00-19:00 for critical departments8 hour targetOQ/PQ, parts traceability, signed service report
SilverMon-Fri 08:00-17:00, planned maintenance focusNext business day parts shippingPM compliance log and replacement schedule
Per-CallOn-demand support for uncovered assets24-72 hour dispatch windowCorrective service report and next-step estimate
Methodology

Four steps that keep biomedical service aligned with regulatory files

The methodology is built for teams that need reliable installed-base support rather than one-time repair activity. Getinge records the scope, supplier controls, software lifecycle responsibilities, and final documentation package before the first site visit, reducing late disputes over who owns calibration, firmware updates, reprocessing instructions, or training sign-off.

  1. 01

    ISO 13485 Scope Definition

    Define the service interface to the hospital QMS, including device family, care area, preventive maintenance cadence, acceptance criteria, and the records that must be retained for internal and external audit.

  2. 02

    21 CFR 820.50 Supplier Controls

    Qualify Getinge field service partners, OEM part flows, loaner equipment, and subcontracted work using documented controls that procurement and quality teams can review before contracting.

  3. 03

    IEC 62304 Software Lifecycle

    Trace firmware updates, cybersecurity patches, connected monitoring changes, and digital service workflows to risk class, release note, rollback plan, and post-update verification evidence.

  4. 04

    Documentation Package

    Deliver service assessment plans, FRACAS records, trend analysis, maintenance certificates, parts traceability, and escalation history in a format that supports value analysis and capital replacement planning.

Request the Full Service Methodology Whitepaper

Share the installed-base profile and Getinge will return a service plan that names coverage tier, document package, and response assumptions for committee review.

Download the Service Methodology