Heidelberg, October 20, 2021 - living brain, a medical device manufacturer based in Heidelberg and operating in Germany, received certification on October 19, 2021 in accordance with the MDR that applies in Europe. This makes living brain the first VR rehabilitation provider in Germany to work according to the high quality standards in the development of medical devices and to have its products certified according to the MDR. The teora mind application for use in neurological rehabilitation is a class 2a product.
The new "Medical Device Regulation 2017/745" came into force on May 26, 2021. After a one-year postponement due to Covid, the MDR thus replaced the previously applicable and much older "Directive 93/42 EEC on medical devices". This was accompanied by a reassessment of many medical devices. Overall, the MDR aims to implement a higher standard and increase patient safety.
In the entire EU, there are currently only 23 notified bodies that are allowed to certify medical device manufacturers according to the MDR. This shortage has led to extended waiting times for manufacturers, especially during the corona pandemic. "We are glad to have found a reliable partner in TÜV Süd and to have successfully mastered our audits. The implemented quality management system ensures the high standards of our product development," says CEO and co-founder Barbara Stegmann. The certification process began in October 2020.
The certification paves the way for market entry in Germany and Europe. "We are very proud to be among the first in our field to receive certification. Together with the clinical data we have just published, we believe we are ready to launch teora mind on the German market," says co-founder and CSO Julian Specht.
teora mind is living brain's first product for cognitive rehabilitation from the teora product line for rehab of brain diseases. Neuroscience, psychology and VR are combined in teora mind to help patients return to everyday life. living brain aims to become the leading provider of digital and data-driven rehab applications for patients with diseases of the brain. The technology is currently used in rehabilitation clinics and rehab centers for patients with neurological diseases. The application, which has been tested in studies and is now certified, is the only one of its kind to help doctors and therapists provide their patients with up-to-date, high-quality rehabilitation for cognitive disorders.
living brain GmbH