UT’s first Medical Device Regulation compliant open-source medical device

Researchers from the Biomechanical Engineering department at the UT have developed their first MDR compliant open-source medical device, a 3D foot plate for medical imaging of hindfoot pathology.

This device helps position the patient's foot for CT imaging, mimicking clinical stress tests. The open-source approach allows users to manufacture and assemble the device at cost price, reducing documentation burdens. The complete MDR documentation will be available on an open-source platform. This initiative aims to improve healthcare accessibility, especially in low- and middle-income settings. The device was developed by Gabriëlle Tuijthof and Eliane Masih from the chair Biomedical Device Design & Production and many others.

You can read the full article in the 14th issue of InnovatieNU from the Fraunhofer Innovation Platform.