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.