Cochlear implant system and neuromodulator startup

Auditory Neuroscience - Development of animal models with hearing loss using drugs and surgery- Implantation surgery of cochlear electrode and implant body - Plasticity in the central and peripheral nervous system- Auditory electrophysiology: multi-unit recording, Electrical stimulation and evoked potentialPreclinical test- Investigation of foreign body reaction after implantation of cochlear electrode and implant body- Analysis of evoked potential following electrical stimulation of auditory nerve- MR phantom study - imaging artifact, heat generation, torque(force) analysis in MR environment- CT imaging study - 3D reconstruction of the human temporal bone with electrode insertion, electrode insertion depth analysis

Product development - Class III medical devices (cochlear implant), Class I surgical tools● Product specification research from international standards, patents, research papers, other companies, etc.● Electronic circuit and PCB design and 3D modelling simulation ● Testing methods development for electronic function verification● Creation of technical files and design control● Selecting and purchasing electronic component, biocompatible materials and so on with understanding of their specifications.● Outsourcing development of product housing and electronic components Medical device approval - KFDA Class III, I and KGMP acquisition● Experience with KFDA approval of medical device (main auditee)● Experience with KGMP acquisition and maintenance (main auditee)● Creation of technical files and documentations for manufacturing● Personnel training on inspection, installation and configuration procedures for product quality assurance.● International standard research, preparing samples and testing for approval with authorized testing laboratoriesClinical investigation monitor under observation of institutional review board.● Clinical investigation protocol review● Product management (manufacture order, testing, delivery)● Check and report the status of products and users on site during surgery and rehabilitation