Beter-Brein

Beter-Brein specializes in digital speech therapy applications, such as the Logopedieapp. These tools are designed to assist with speech and language rehabilitation, offering structured exercises for articulation, fluency, and communication skills. The devices are intended for use in both clinical and home-based therapy settings.

Beter-Brein is based in the Netherlands. Its products are developed as software-as-a-medical-device (SaMD) applications and comply with EU regulatory requirements. Since these devices fall under Class I classification, they must meet EU Medical Device Regulations (MDR) or Medical Device Directive (MDD) standards, depending on the applicable timeline, and are registered in the EUDAMED database.

Yes, Beter-Brein’s devices are registered in the EUDAMED database, which is the official EU registry for medical devices. This listing ensures transparency and compliance with EU regulatory requirements for medical devices, including those classified as Class I.

Beter-Brein’s devices are classified as Class I medical devices under EU regulations. This classification is typically assigned to low-risk devices, such as speech therapy software, where the risk to patients is minimal. Classification is determined based on factors like intended use, duration of use, and potential risks, as outlined in EU Medical Device Regulations (MDR) or the Medical Device Directive (MDD).