提高医疗器械检测实验室评审有效性探讨

How to Improve the Accreditation Validity of Medical Devices Testing Laboratory

医疗器械产品的安全性和有效性直接关系人民群众的生命健康。因此,提高医疗器械器械检测实验室认可的有效性,是社会各方都十分关注的问题。该文针对医疗器械检测实验室的特点,阐述了目前实验室认可评审中存在的一些问题,结合工作实践经验,对提高实验室评审的有效性提出了改进的建议。

The safety and effectiveness of medical devices are directly related to human health. Therefore, how to improve the accreditation validity of medical devices testing laboratory has been the focus of attention from every corner of society. With respect to the characteristics of medical devices testing laboratory, this paper represented the existing issues during the accreditation and evaluation of testing laboratory, put forward some improvement suggestions on how to improve the validity of testing laboratory evaluation based on the practical experience.