Optimalizace rizikové analýzy v procesech životního cyklu produktů

Abstract

This bachelor thesis focuses on the optimization of risk management in the development and manufacturing of medical devices, with particular emphasis on practical applicability for small and medium-sized manufacturers. The aim of the thesis was to design a clear and systematic risk management process compliant with the requirements of the ČSN EN ISO 14971 standard, while remaining feasible within real-world industrial conditions. The theoretical part summarizes fundamental principles and methods of risk management, including FMEA, benefit-risk analysis, and post-market surveillance. The practical part is based on the analysis of a real risk management documentation for a specific medical device, identification of weak points, and the proposal of an optimized process. The final output includes a practical implementation guide and a control checklist designed to support the consistent application of risk management in everyday practice. The thesis provides specific recommendations for manufacturers and contributes to improved quality, safety, and transparency of risk management processes in the medical device industry.