Aplikace managementu rizik u výrobce zdravotnických prostředků

Abstract

The Diploma Thesis focuses on importance to effectively implement and integrate the risk management into the Quality Management System at medical device manufacturer. At the beginning, there is illustrated a theme background and an introduction of ARROW International CR, a.s. including the description of risk management application within the organization. Analytical part contains an analysis of risk management weaknesses and a proposal to reduce selected risks, where on real case studies new original methodology how to reduce the risks is being introduced. In conclusive sections, proposed actions are evaluated and in addition, there are also listed the options how to further improve the risk management processes, mainly with using the human factors engineering.