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1概述医学装备不良事件报告制度和对医学装备进行再评价是医学装备上市后监督管理的重要环节,制度和管理办法是否有效实施,将直接影响到患者的健康利益和医学装备临床应用的安全性和有效性。
1 Overview The medical equipment adverse event reporting system and the re-evaluation of medical equipment are important links in post-marketing supervision and management of medical equipment. Whether the system and management methods are effectively implemented will directly affect the health benefits of patients and the safety of clinical application of medical equipment. And effectiveness.