{"title":"[金属增材制造医疗器械生产中的关键控制点和案例研究]。","authors":"Xin Jiang, Minliang Zhou","doi":"10.3969/j.issn.1671-7104.230217","DOIUrl":null,"url":null,"abstract":"<p><p>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.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2024-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"[Critical Control Points and Case Studies in the Production of Metal Additive Manufacturing Medical Device].\",\"authors\":\"Xin Jiang, Minliang Zhou\",\"doi\":\"10.3969/j.issn.1671-7104.230217\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>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.</p>\",\"PeriodicalId\":52535,\"journal\":{\"name\":\"中国医疗器械杂志\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2024-01-30\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"中国医疗器械杂志\",\"FirstCategoryId\":\"1087\",\"ListUrlMain\":\"https://doi.org/10.3969/j.issn.1671-7104.230217\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"Medicine\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"中国医疗器械杂志","FirstCategoryId":"1087","ListUrlMain":"https://doi.org/10.3969/j.issn.1671-7104.230217","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"Medicine","Score":null,"Total":0}
[Critical Control Points and Case Studies in the Production of Metal Additive Manufacturing Medical Device].
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.
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