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[Analysis of Technical Evaluation for Current Regulation of 3D Printed Customized Medical Device].

Zhijin Fan, Neng Xie
Zhongguo Yi Liao Qi Xie za Zhi = Chinese Journal of Medical Instrumentation 2018 July 31
This paper summarizes the current research status of 3D printed customized medical devices regulations in US and EU. Based on the discussion of 3D printed customized medical devices in the US and the European Union, some thoughts are put forward from design, manufacturing, testing and other aspects.

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