Bachelor Projects

Development of Regulatory Documentation for a Novel Neurorehabilitation Device: Preparation for FDA and Swissmedic Compliance

Stroke is a leading cause of long-term disability, affecting millions annually and necessitating innovative approaches to rehabilitation. The Rehabilitation Engineering Laboratory (RELab) at ETH Zurich is developing a novel closed-loop neurorehabilitation device that integrates real-time motion tracking with non-invasive brain stimulation to enhance neural plasticity and promote motor recovery in stroke patients. To advance this technology toward clinical trials, comprehensive regulatory documentation is essential to meet the stringent requirements of the U.S. Food and Drug Administration (FDA) and Swissmedic. This project focuses on preparing an Investigational Device Exemption (IDE) application for the FDA and supporting documentation for Swissmedic compliance, including technical descriptions, risk analyses, and clinical study protocols. The student will conduct literature reviews, draft regulatory documents, and support risk management in accordance with ISO 14971, contributing to the device’s regulatory pathway. This work offers a unique opportunity to gain expertise in medical device regulation, bridging biomedical engineering and neuroscience, and advancing a transformative solution for stroke rehabilitation. Show detailsaddremove