Vitruvia Medical, which specializes in circular systems for highly complex medical products, particularly robot-assisted surgery, now also holds DIN EN ISO 13485:2016 (KRINKO/BfArM) certification.

This means that Vitruvia Medical is now certified to reprocess all surgical instruments, including those classed at the highest “critical C” risk level. These include flexible endoscopes as well as all instruments and optics for robot-assisted surgery which are authorized for reprocessing by the manufacturer.

Reprocessing has to meet exceptionally high standards to ensure the highest level of patient safety, as well as the hygienic and functional safety of the reprocessed medical device. For this reason, the German Medical Devices Operator Ordinance (MPBetreibV) requires that facilities reprocessing “critical C” risk-level medical devices must have a quality management system that is certified in line with DIN EN ISO 13485 and takes the Robert Koch Institute’s “KRINKO/BfArM Recommendation” into account.

“This certification allows us to offer an efficient and quality-assured reprocessing service to hospitals for all surgical instruments both for robotics and endoscopy,” says Vitruvia’s Managing Director Rainer Grabow, explaining this innovative company’s new milestone. These two service modules will be offered to hospitals under the names of RobotiQ and EndoscopiQ.

The Vitruvia Medical Group has opened a 2,000 sqm Circular Clinic Supply Center for robotic instruments in Schönebeck, near Magdeburg – the first in Europe. After two years of renovation and upgrades, hospital instruments are now being prepared for reuse here under cleanroom conditions. With this sustainable concept, hospitals save both investment and operating costs when using robot-assisted surgical systems and also avoid the potential underuse of their own circular systems.

About Vitruvia

Vitruvia is Europe‘s foremost technology company in the healthcare sector of the circular economy. As a supplier of innovative circular systems for highly complex medical devices, particularly in robot-assisted surgery, Vitruvia supports hospitals in the transformation of their ORs to higher value added, increased safety and maximum resource efficiency.
The company has offices in Berlin, Hamburg, Rietheim-Weilheim, Schönbeck/Elbe and Anglikon/Switzerland.

Press contact:
Vitruvia Medical AG
Beate Schemmer
Leiterin Marketing
T +49 (0)30 588 00 57 16
schemmer@vitruvia-med.com