医疗器械设计开发过程经验分享

【题记】

进入2017年，笔者感觉国内市场一下子对医疗器械的研发重视了起来，突出表现在各个机构推出了研发流程或研发法规等相关培训，层出不穷。笔者从自身十多年的研发质量的维度进行了研发过程经验的分享，仅代表个人观点，供行业朋友们学习，借鉴。

【Introduction】

Going  into 2017, I feel that china’s industry has greatly improved their  attention to Medical Devices research and development. This can be seen  from the many institutions that are pushing out a diverse range of  training programs regarding devices research process and regulations.  The author shared a unique perspective based on more than 10 years of  experience in the industry. This article only repres.