Bachelor Projects
Regulatory-Compliant Medical Device Packaging Design & Prototyping
Design and prototype a regulatory-compliant, brand-aligned packaging solution for a medical device. The work includes translating needs into packaging requirements, cross-checking existing box label content against applicable regulatory documentation and standards in collaboration with the QMS (e.g., MDR/ISO), iterating visual/branding design, and building physical mock-ups (including some 3D printing). Material selection and pricing/supplier comparisons may be performed to ensure the solution is scalable and manufacturable.
Keywords
Medical device packaging; Labeling compliance; EU MDR; ISO standards; QMS; Prototyping; 3D printing; Branding & graphic design; Material selection; Cost comparison; Manufacturability; Documentation
Labels
Semester Project , Internship , Bachelor Thesis , Master Thesis
PLEASE LOG IN TO SEE DESCRIPTION
More information
Published since: 2026-02-13 , Earliest start: 2026-02-22 , Latest end: 2026-09-30
Organization Rehabilitation Engineering Lab
Hosts Quast Max , Viskaitis Paulius
Topics Arts , Medical and Health Sciences , Engineering and Technology , Commerce, Management, Tourism and Services , Chemistry
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.
Keywords
regulatory affairs, medical device, non-invasive brain stimulation, FDA, Swissmedic, investigational device exemption, IDE, stroke rehabilitation, compliance
Labels
Semester Project , Internship , Bachelor Thesis , Master Thesis
PLEASE LOG IN TO SEE DESCRIPTION
More information
Published since: 2026-05-28 , Earliest start: 2026-01-01 , Latest end: 2026-10-01
Organization Rehabilitation Engineering Lab
Hosts Donegan Dane , Viskaitis Paulius
Topics Medical and Health Sciences , Engineering and Technology