摘要
医疗器械产业具有研发周期长、跨度大、难度高、生产标准严格、安全方面要求高等特性,这也注定了医疗器械研发项目的高风险。基于此,文章首先探究医疗器械项目研发所面临的风险问题,进而提出相应的管理措施。
The medical device industry has the characteristics of long research and development cycle, large span, high difficulty, strict production standards and high safety requirements, which also dooms to the high risk of medical device research and development projects. Based on this, this article first explores the risk problems faced by medical device project development, and then puts forward corresponding management measures.
引文
[1]吴志敏.探究医疗器械生产和生产后风险管理[J].商,2015(13):26-27.
[2]何智韧,杨琳.医疗器械项目研发面临的风险问题与管理措施[J].中国高新技术企业,2017(2):101-102.
[3]崔佳,吴郦媛.在用体外诊断类医疗器械风险分析及对策研究[J].中国医疗器械信息,2016(11):29-30.