The project includes an analysis phase on the procedure for in-house manufactured medical devices at three different clinics. The results of existing preliminary research on affected products are to be analyzed in order to achieve a correct procedure according to MDR 2017/745 and MPG 2021. The first project report includes the analysis about the current "In-House" manufacturing process and the procedure to create the technical documentation of the products. This is to be carried out per clinic with reference to details of the products concerned. In the subsequent project phase, an individual concept assessment is carried out for the three clinics based on three products selected in the analysis phase. This includes the classification of individual products, the evaluation of measures
already taken for this products, the compilation of the necessary technical documentation, the evaluation of the implemented software development process and the evaluation of the implementation of a quality management system.
Background: Traumatic brain injury (TBI) is a leading cause of death and disability among young adults. The impairment of the often very young patients in daily life is a heavy burden for the affected person and leads to high healthcare costs. In recent years, electrostimulation of neurons has been suggested a promising approach to induce functional recovery of injured neuronal connections. However, standard electrode stimulation techniques require invasive methods and wiring of the patient.
Purpose: We aim to combat TBI-induced disabilities by re-establishing neuronal connectivity. We will use light-sensitive semiconductors (photocaps) made from industrial colorants. They are easily available, stable, and non-toxic. Photocaps enable electrical stimulation of neurons with safe light intensities without the need for external wiring.
Hypothesis: We suppose that the stimulation of neuronal cells via light-activated photocaps fosters functional recovery after TBI.
Approach: In a multidisciplinary research approach we investigate the photocaps’ performance and effects on living systems. Cultured cells are an invaluable tool to develop optimal stimulation parameters before progressing to healthy and injured brain tissue. We will investigate the optimal time window after TBI in which stimulation yields the most extensive regenerative results. Our interdisciplinary research program brings together young independent researchers with backgrounds from neuroscience (Dr. Muammer Ücal), structural biology (Dr. Karin Kornmüller), electrophysiology (Dr. Susanne Scherübel) and electrical engineering (Dr. Theresa Rienmüller). Experiments will be conducted at the Medical University of Graz and Graz University of Technology.