RESUMO
This article describes softwares and their functions in each phase of 3D printing process in medical device production, and gives the advices on supervision. For software with specific medical purposes, the registration of the software should be carried out. The softwares used in the printing process need to be verified according to the corresponding risk.
Assuntos
Equipamentos e Provisões , Impressão Tridimensional , SoftwareRESUMO
Recent years, the development of medical devices kits is rapid. How to make the technical evaluation of medical devices kits more perfect bases on the two major principles of safe and effective, and to make kits in the market more normative and orderly, these issues for technical evaluation have to be considered. This article makes a study on current situation of production, classification of management and registration status, combined with existing regulations and related standards, and discusses technical evaluation related issues.
