摘要
该文针对中小型医疗器械制造企业首次接受美国FDA常规检查所需做的准备工作展开讨论,结合实际工作经历对FDA常规检查流程中可能遇到的问题进行研究。针对从提交FDA常规检查申请到检查通知的接收以及问题的识别和解决,再到检查的陪同及完成检查全过程的准备工作提出建议。该文特别强调参照QRS820中"应对措施"部分对发现的问题进行补救。文中引入了美国企业应对FDA检查的主流方法,旨在对处于国际化背景下的国内中小型医疗器械制造企业有所帮助和启示。
This paper discusses the necessary preparation work flJr routine FDA inspection by small and medium- sized medical device manufacturers from the inspection notification received. The problem identification and solution in FDA inspection process were investigated and suggestions were provided. This article emphasizes Remediation in QSR820 and the implementation method of the Remediation. The paper introduced the mainstream methods used by American companies for FDA inspection, which may provide help and inspiration to small and me- dium- sized medical device manufacturers in the international background.
出处
《生物医学工程学进展》
CAS
2016年第2期120-124,共5页
Progress in Biomedical Engineering
基金
沪江基金研究基地专项(D15015)
