医疗器械产品设计开发过程的质量管理

Quality Management of Medical Device Product Design and Development Process

良好的设计开发过程控制才能产出高质量的医疗器械产品,设计开发管理是企业质量管理体系运行中的重点和难点。文章依据我国《医疗器械生产质量管理规范》的要求,对设计开发过程进行分析,探讨质量管理的思路与方法。

Well design and development in process monitoring would promise high-quality medical devices, thus, design and development management becomes the key point as well as the nodus in the operation of enterprise quality control system. According to the Norm of Manufacture and Quality Control of Medicial Devices, this article aims at the analysis of design and development process, and the study of mentality and method in quality management.