摘要
医疗器械设计和开发过程的合规性是"产学研"合作产业化的关键点。文章汇总设计和开发过程不合规导致的突出问题,对其原因进行分析,并结合《医疗器械生产质量管理规范》的要求阐述食药监部门现场检查的关注点。
The legality of the design and development process of medical equipment is the key point on"Industry-University-Research Collaboration".This article summarizes the outstanding problems caused by the unregulated design and development process,and analyses the reasons.In combination with the requirements of Good Manufacturing Practices Of Medical Devices,the attention of the field inspection of the department of food and drug administration is expounded.
作者
郭嘉杰
许广宁
张龚敏
胡燕娴
康涛
GUO Jia-jie;XU Guang-ning;ZHANG Gong-min;HU Yan-xian;KANG Tao(Guangdong Food and Drug Administration Center for Evaluation&Certification,Guangdong Guangzhou 510080)
出处
《中国医疗器械信息》
2018年第5期20-23,共4页
China Medical Device Information
关键词
产学研
医疗器械
设计和开发过程
合规性
industry-university-research collaboration
medical device product
design and development process
compliance
