Maintenance & Service for medical devices

In medical technology, maintenance is regulated, not discretionary. The German Medical Devices Operator Ordinance requires safety checks for devices listed in Annex 1 and metrological checks for measuring devices, each within set intervals and carried out by people with demonstrated expertise. Whoever services must document it; whoever does not service is liable.

Operators and manufacturers therefore weigh different things than in ordinary machine service. How quickly is someone on site when a device fails during surgery? How long are spare parts available — the MDR expects supply across the expected lifetime. Does the provider work to the manufacturer's specifications, and does the intervention void the device's conformity? Replacing parts that are not released can turn a service provider into a manufacturer.

The providers listed here range from manufacturer-tied service through independent inspection providers for statutory safety and metrological checks to the reprocessing of used instruments. When filtering, look at which device groups someone is qualified for — few providers cover the full range from endoscopy to high-frequency surgery.