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Vital Control Points in the Production of Metal Additive Manufacturing Medical Devices：from the Perspective of Risk Management
【Abstract】
1.Current Regulatory Status of Metal Additive Manufacturing Medical Devices
2.Vital Control Points in the Production of Metal Additive Manufacturing Medical Devices
3.Case Studies【Bio】
Jiang Xin, a Senior Engineer, currently serves as the Deputy Director of the Passive Device Verification Department at Shanghai Medical Device and Cosmetics Evaluation and Verification Center, as well as the Leader of the Medical Device Inspection Team at the Shanghai Municipal Drug Administration. She primarily engages in the field verification of medical devices. As the project leader and key researcher, she has participated in over ten research projects sponsored by the Ministry of Science and Technology, the Ministry of Industry and Information Technology, and the National Medical Products Administration. She also serves as an editorial board member of the key book publication planning project of China's "14th Five-Year Plan", titled "3D Printed Medical Devices", and has been involved in drafting more than ten industry standards and group standards, including "Additive Manufacturing for Medical Applications—Requirements for Control and Validation of Metal Powder-Bed Electron Beam Fusion Process".
