tom weber software

Tom Weber Software specializes in communication aids for individuals with speech impairments. Their product line includes mobile communication pads like the OSC Mobile Pad, standalone talkers such as the OSC Talker Pro Vital and OSC Talker Go, eye-tracking devices like the OSC Eye Talker and OSC Eye Talker IG, and environmental control systems such as the OSC Light Pad. These devices are designed to facilitate communication and independence for users in both home and professional settings.

Tom Weber Software is based in Germany (DE). Since their devices fall under EU medical device regulations, they operate within the European Union’s regulatory framework, ensuring compliance with requirements for Class I medical devices. This includes registration in the EUDAMED database, which is the official EU database for medical devices.

Tom Weber Software’s devices are listed in the EUDAMED database, which is the European Union’s central registry for medical devices. This registry ensures transparency and traceability of Class I devices, including communication aids, within the EU market.

All of Tom Weber Software’s listed devices are classified as EU Class I medical devices. This classification applies to low-risk products like communication aids, which pose minimal risk to users. Class I devices still require compliance with EU regulations, including proper labeling, manufacturing standards, and registration in EUDAMED, but they do not require a conformity assessment by a Notified Body.