Critical Control Points and Case Studies in the Production of Metal Additive Manufacturing Medical Device
10.3969/j.issn.1671-7104.230217
- VernacularTitle:金属增材制造医疗器械生产环节关键控制点与案例研究
- Author:
Xin JIANG
1
;
Minliang ZHOU
Author Information
1. 上海市医疗器械化妆品审评核查中心,上海市,200020
- Keywords:
metal additive manufacturing;
medical device;
production quality management;
case studies
- From:
Chinese Journal of Medical Instrumentation
2024;48(1):94-98
- CountryChina
- Language:Chinese
-
Abstract:
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.
