Caritas Hospital St. Josef is the first QUMEA hospital in Germany
You could mistake it for a smoke detector: the new anonymous mobility sensor at Caritas Hospital St. Josef. Mounted inconspicuously on the ceiling, the high-tech device will be used for patients at risk of falling. The hospital is the first in Germany to rely on the...
Seewadel, Axelion & QUMEA – 3 partners for 1 ecosystem
The safety of its residents and caregivers is very important to Seewadel - Center for Health and Aging. In the new center, the care teams will therefore be supported by the early warning system QUMEA to prevent falls and to be there in good time where help is needed....
Hirslanden relies on mobility monitoring from QUMEA
«QUMEA has not only led to a significant reduction in falls, but has also increased the safety of nursing staff and helped us to save considerable costs on patient care staff» enthuses Clinic Director Marco Gugolz. The Hirslanden Clinic in Zurich is making the largest...
Cantonal Hospital Aarau relies on QUMEA
The Stroke Center of the Cantonal Hospital Aarau (KSA) remains in the pioneering role: In 2013, it was the first Stroke Center in Northwestern and Central Switzerland to be officially certified, and it has just become the first Stroke Center to be equipped with the...
CHF 1.2M for research in digital-health powered prevention
Today an Innosuisse project to strengthen hospital care teams and doctors is launched. Digital health startup QUMEA (‘maximum prevention – minimum intrusiveness’) will work with partners ARTORG Center for Biomedical Engineering Research at the University of Bern and the Bern University of Applied Sciences (BFH)…
QUMEA opens Swedish office
QUMEA steps into the Nordic market and opens a Swedish subsidiary. QUMEA® is the Swiss technology-leader for fall prevention and mobility monitoring in hospitals and nursing homes. As of May 2022 they are opening a subsidiary in Sweden headquartered in Stockholm....
Regulatory Statement & Conformity
MDR Statement
QUMEA Care is not a medical device according to Regulation (EU) 2017/745 and therefore does not fall within its scope of the same.
QUMEA Care is intended for the prevention of injuries. According to Article 2 paragraph 1 of Regulation (EU) 2017/745 (European Union Medical Device Regulation - MDR), the prevention of an injury is not a medical purpose. The movement and activity data as recorded and displayed by QUMEA Care are ultimately intended to be used to prevent injuries. The device is not intended to be used for "diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury" and accordingly, not for a specific medical purpose.
QUMEA Mobility Sense is a Class 1 medical device according to Regulations (EU) 2017/745 (European Union Medical Device Regulation - MDR) and MepV (2020/812.213).
QUMEA Mobility Sense is intended to be used for prevention of Decubitus ulcers and pressure areas (ICD L89). The product is solely used to inform the caretaker when a patient did not show a certain level of mobilization for a specific amount of time. The required level of mobilization is defined as a change in posture of the recumbent subject (e.g. turning from supine to lateral position). No diagnostic or therapeutic decisions can be made based on the output of the data.
Conformity (CE)
QUMEA sensor products are in conformity with European health, safety, and environmental protection standards.
QUMEA AG CHRN: CHRN-MF-20002870
Classification and conformity documentation, as well as additional documents, are available upon request from QUMEA AG.
Impressum
Verantwortlich für den Inhalt:
QUMEA AG
Westbahnhofstrasse 3
CH-4500 Solothurn
+41 (0)32 525 60 50
info@qumea.com
UID: CHE-439.197.016
Rechtsform: Aktiengesellschaft
Kontaktperson:
Cyrill Gyger
Bitte beachten Sie auch die Datenschutzerklärung von QUMEA.
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