除非获得有效的豁免批准,QS法规适用于以销售为目的的人用医疗器械制成品。
The QS regulation applies to finished devices intended to be commercially distributed for human use unless there is an approved exemption in effect.
适用于:空气压缩机、医疗器械、磨浆机等机械。
Applications: Air compressors, medical instruments and small machine tools, etc.
适用于公司所有医疗器械产品风险管理过程。
Apply to the risk management process of all medical devices.
应用推荐