Review

The Progress of Standardization and Quality Control of Additive Manufacturing Medical Device

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  • Medical Device Control, National Institute of Food and Drug Control, CFDA

Received date: 2018-03-19

  Online published: 2020-07-23

Abstract

3D printing is used in the manufactory of medical device.This technology could be used in the fabrication of dental medical device,orthopedic and cardiovascular medical device.Because of the uniqueness of this technology,the research of quality control should cover raw material,the process control,facility,data transmission and risk control.Besides the quality control technology,it is important to set up standards.The process control and standardization could improve the risk control and quality of additive manufacturing in medical area.In this paper,the progress of standardization and quality control of additive manufacturing medical device was reviewed.

Cite this article

HAN Qianqian,LI Mao,WANG Chunren,YANG Zhaopeng . The Progress of Standardization and Quality Control of Additive Manufacturing Medical Device[J]. Journal of Tissue Engineering and Reconstructive Surgery, 2018 , 14(3) : 121 -135 . DOI: 10.3969/j.issn.1673-0364.2018.03.001

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