Implementace rizikového managementu ve vývoji a výrobě zdravotnických prostředků

Abstract

The thesis deals with the implementation of risk management in the development and production of medical devices according to the standard ČSN EN ISO 14971:2019. The objective was to evaluate the level of implementation of risk analysis, which was created based on FMEA method. The theoretical part deals with the risk management process both in general terms according to the standard ČSN EN ISO 31000:2018 and according to the standard ČSN EN ISO 14971:2019, which focuses risk management in medical devices. Also the different methods used for risk analysis have been reviewed. In the practical part, the level of risk management implementation was reviewed and then the weaknesses of each documentation were identified. Based on the information identified, recommendations were made, mainly concerning the inclusion of the entire product life cycle in the risk analysis and the importance of collecting information in the manufacturing and post-manufacturing phases.