Vitruvia Medical AG

  • ISIN: CH0461931419
  • Land: Schweiz

Nachricht vom 28.07.2021 | 10:00

Vitruvia Medical AG: Successful certification for the reprocessing of 'critical C' devices - Vitruvia Medical now also providing circular systems for highest risk-level medical devices

DGAP-News: Vitruvia Medical AG / Key word(s): Regulatory Approval/Product Launch
28.07.2021 / 10:00
The issuer is solely responsible for the content of this announcement.

Successful certification for the reprocessing of "critical C" devices - Vitruvia Medical now also providing circular systems for highest risk-level medical devices

Schönebeck, July 28, 2021 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) 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 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 EndoscopyIQ.

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.

Further information:

Press contact:
Wolfgang Böhm
T +49 30 44 33 61 - 33

28.07.2021 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

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