MEDICAL DEVICE MANUFACTURER

teora® mind is a certified class IIa medical device under the MDR

teora® mind is a certified class IIa medical device under the Medical Device Regulation (Directive 2017/745), which came into effect in 2021 and applies throughout Europe. The MDR will replace the previously applicable Medical Devices Directive (MDD) and is intended to further improve patient safety. Class IIa encompasses medical devices for which the risk to patients is classified as low to moderate. Other examples of this risk class include digital blood pressure monitors and hearing aids. Based on this certification, teora® mind bears the CE mark (CE 0123).

You can download our MDR certification from our download area if desired.

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Note: teora® body and teora® platform are not certified medical devices.

Quality assurance and accreditation

To become a certified medical device manufacturer under the MDR, every manufacturer must have its products undergo a comprehensive evaluation, including clinical trials and a risk assessment. At the same time, the products must comply with applicable regulations and meet the highest quality assurance standards. To ensure this, we employ a quality management system that complies with the DIN EN ISO 13485 standard—a standard specifically developed for companies in the medical device industry. Our system covers all areas of the company related to the development, manufacturing, distribution, and servicing of our medical devices. This allows us to not only ensure that our products meet legal requirements but also to continuously work on improving our performance.

To maintain our certification, regular audits by an accredited body are required. Our audits and certification are conducted by TÜV Süd.

If you have any questions about our certification, please feel free to contact us.

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