Quality is built into the equipment, consumables, workflows and documentation — not added at the end.
Standards-based design
Equipment is designed with EC standards where applicable and uses CE-marked critical components. Cycle data, alarm records and traceability interfaces support validation and daily quality control.
Closed-loop traceability
TrakOne and equipment-level traceability connect instruments, cycles, operators and release. Barcode, data-matrix and RFID options allow hospitals to choose the appropriate level of detail.
Contract CSSD quality systems
Twelve quality systems cover the complete contract CSSD workflow, from reception and cleaning to packaging, sterilization, release and logistics.
Specific certification scope and regulatory documentation depend on the product and market. Please contact us for the current certificate package.