通过调研上海市宝山辖区内医疗器械生产企业成品检测现状以及检测人员的能力,了解辖区内医疗器械生产企业成品检测存在的主要问题和检测人员检测能力的实际状况,为进一步提高医疗器械检测人员检测能力和医疗器械生产企业监管提供参考建议。 By investigating the status quo of the finished product testing of medical device manufacturers in Baoshan District of Shanghai Municipality as well as the capability of the inspectors, it is necessary to know the main problems existing in the finished product testing of the medical device manufacturers in the area and the actual status of the inspectors’ ability to detect them. In order to further improve the testing of the medical device inspectors Ability and regulation of medical device manufacturers to provide reference.