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Ascom’s Digistat Care software has obtained the medical device product certification (class IIb) according to the Medical Device Regulation of the European Union.
The new Medical Device Regulation (MDR) came into force in 2017 and is applicable since 26 May 2021, replacing the prior Medical Device Directive (MDD). The new regulation ensures a consistently high level of health and safety protection for EU citizens using medical devices. Furthermore, the MDR has been adapted to the technological and scientific progress which have occurred in this sector over the last 20 years. Therefore, the MDR certified medical devices ensure a significantly higher level of quality and safety compared to MDD certified devices. An MDR certification is applicable in all EU and EFTA.
Digistat Care, as part of the Digistat Suite, is an integrated critical care patient and clinical alarm management system designed to support the daily activities of staff and help achieve safer, more effective care. The Ascom Digistat Suite is a comprehensive modular suite of clinical workflow software and an advanced patient data management system for acute care departments. In the field of patient and alarm management systems, Ascom is one of the first companies to obtain the MDR certification for a class IIb medical device software, the second highest risk classification under the MDR.
Jeannine Pilloud, Ascom CEO, says: “The MDR certification for Digistat Care is an important step for the Digistat Suite, a software solution centerpiece for our customers in healthcare. We are proud to have obtained this certification, which is a confirmation of Ascom’s cutting-edge design and development technologies and state of the art clinical software solutions offering.“