摘要
本文收集并分析了2004年-2010年世界范围内的25家医疗器械生产企业接受到的FDA 26封警告信(warning letter),以帮助国内医疗器械生产企业更好的理解美国医疗器械质量体系法规(CFR-part820,简称QSR820)的关注重点,以及FDA检查员的关注点。
Collection and analysis of 26 warning letters derive from 25 Medical device manufacturers which took place from 2004 to 2010.In this way,that is expected to help domestic medical device manufacture to better understand the emphasis of CFR part 820 and FDA inspection concerntration.
出处
《中国医疗器械信息》
2010年第12期45-48,共4页
China Medical Device Information
