Analýza rizik ve vybrané společnosti

Abstract

This thesis focuses on the application of the FMEA method in the field of medical devices. The main objective is to meet the legislative requirements imposed on manufacturers of these devices, primarily through risk analysis. The introductory part of the thesis provides a basic overview of the issue, including the historical development of the FMEA method and its possible applications. This helps the reader gain the necessary context and understanding of key concepts. The practical part of the thesis describes the company for which the risk analysis is conducted, along with its product portfolio. Subsequently, a risk analysis methodology is proposed, forming the basis for the application of the FMEA method. The final section evaluates the analysis process and assesses the overall contribution of this thesis.