【摘要】 近几年,医疗器械产业发展迅猛,但同时也暴露出很多问题和风险。为了有效识别医疗器械产业链的风险,利用FMEA方法识别风险来源,定量评估,对风险进行分析,并提出风险应对策略。通过统计方法确定风险水平,同时赋予风险水平不同的权重,以便解决FMEA方法忽略了风险因子之间的相对重要性。根据研究结果,确定医疗器械产业链的临界水平风险和半临界水平风险的主要来源,针对风险来源对供应商、组织、客户以及环境提出相应风险的高效处理措施。更多还原

【Abstract】 In recent years, the medical device industry has developed rapidly, but at the same time, many problems and risks have been exposed. In order to effectively identify the risks of the medical device industry chain, FMEA method is used to identify the risk sources, quantitative assessment, risk analysis and risk response strategies are proposed. In order to solve this problem, FMEA method ignores the relative importance of risk factors. According to the research results, the main sources of critical level risk and semi critical level risk of medical device industry chain are determined, and the corresponding effective risk treatment measures for suppliers, organizations, customers and environment are put forward.更多还原