With the development of additive manufacturing(AM)technology and the promotion of precision medicine concepts,AM medical devices are gradually being widely used in the fields of customized dentistry and personalized implantation.However,in the registration and certification process,there is still a lack of evaluation guidelines and targeted national and industry standards for AM medical devices in China.In addition,the uncertainty of AM technology itself in the manufacturing process will introduce significant risks.Therefore,it is urgent to carry out quality control throughout the entire lifecycle of medical devices,including design,raw materials,equipment,molding,and post-processing,and improve the domestic AM medical device technical standards and regulatory system.Based on this,the development status of AM medical device industry was reviewed in this study,in order to promote the high-quality development of AM technology in the medical device industry.
关键词
增材制造/医疗器械/标准体系/审评指导原则/全生命周期质量控制
Key words
Additive manufacturing/Medical devices/Standard system/Guiding principles for evaluation/Quality control throughout the entire lifecycle
维普
万方数据