Objective: This paper introduces the key content and background of Technical Review Guidance for the Registration of Personalized Additive Manufacturing Medical Devices of Passive Implantable Bone, Joint and Oral Hard Tissues.
Methods: The core contents and importance of the construction of personalized design validation and verification and additive manufacturing system are described respectively.
Results: The personalized design needs to be carried out under the control of interactive cooperation between healthcare professional and engineer. And the performance of personalized device must be validated and verified completely. At the same time, in view of the particularity of the quality management system of additive manufacturing, the technical focus is expounded.
Conclusions: New ideas and methods shall be used in evaluate and administrate personalized additive manufacturing medical device.
Keywords: personalized medical device; quality management system of additive manufacturing; validation and verification of personalized design.