The critical control points in the production quality management of metal additive manufacturing medical devices,including personnel,hardware,design and development,procurement control,production management and quality control are summarized from the perspective of supervision.The typical cases are analyzed to provide reference for medical device regulatory authorities and enterprises.
关键词
金属增材制造/医疗器械/生产质量管理/案例研究
Key words
metal additive manufacturing/medical device/production quality management/case studies