摘要
医疗器械设计和开发输入是医疗器械质量管理体系中关键环节,标准和法规方面对设计和开发输入的要求日益完善。同时鉴于设计和开发输入对产品设计和开发以及全生命周期质量管理的影响,应在监管科学研究中加强监管新方法的研究,监管法规应进一步细化要求。提升设计和开发输入质量及其在医疗器械产品性能评价中的应用,有助于推动医疗器械行业创新和高质量发展。
Medical design input is a key link in medical device quality management system, the requirements of the design input in the standards and regulations are becoming perfect. Meanwhile, due to its effect on product research and development as well as the quality management in the whole life cycle of design input, research of new methods of design input regulation should be strengthened in regulatory science, and the requirements of regulation should be more specific. Promotion of the quality of design input and application in performance evaluation of medical device could be conducive to innovation and high-quality development of medical device industry.
作者
丁金聚
郭亚娟
刘斌
Ding Jinju;Guo Yajuan;Liu Bin(Center for Medical Device Evaluation,National Medical Products Administration,Beijing 100081,China)
出处
《中国药事》
CAS
2020年第12期1372-1377,共6页
Chinese Pharmaceutical Affairs
基金
国家重点研发计划项目资助(编号2018YFC1106700)。
关键词
设计和开发输入
医疗器械
性能评价
全生命周期
设计和开发
design input
medical device
performance evaluation
whole life cycle
research and development