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teora mind is a certified Class IIa medical device in accordance with the Medical Device Regulation (Directive 2017\/745), which came into force in 2021 and applies throughout Europe. In the future, the MDR will replace the Medical Devices Directive (MDD) currently in force and is intended to further improve patient safety. Class IIa comprises medical devices for which the risk to patients is classified as low to medium. Other examples of this risk class are digital blood pressure monitors or hearing aids. Based on this certification, teora mind bears the CE mark (CE 0123).<\/p>\n
If required, you can download our MDR certification in our download area.<\/p>\n
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To become a certified medical device manufacturer under MDR, each manufacturer must have a comprehensive evaluation of the devices, including clinical studies and a risk assessment. At the same time, the products must comply with applicable regulations and meet the highest quality assurance requirements. To ensure this, we apply a quality management system that complies with the DIN EN ISO 13485 standard. A standard developed specifically for medical device companies. Our system covers all areas of the company related to the development, manufacture, distribution and service of our medical products. This enables us not only to ensure that our products comply with legal requirements, but also to work continuously on improving our performance.<\/p>\n
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Regular audits by an accredited body are required to maintain our certification. Our testing and certification is carried out by T\u00dcV S\u00fcd.<\/p>\n