Discussion on Supervision of 3D Printing Medical Device Related Software.
10.3969/j.issn.1671-7104.2018.02.013
- Author:
Yingfeng ZHU
1
;
Haiyin ZHENG
2
Author Information
1. Center for Certification & Evaluation, SHFDA, Shanghai, 200020.
2. Shanghai Hospital of Traditional Chinese Medicine, Shanghai, 200071.
- Publication Type:Journal Article
- Keywords:
3D printing;
medical device;
software;
supervision
- MeSH:
Equipment and Supplies;
Printing, Three-Dimensional;
Software
- From:
Chinese Journal of Medical Instrumentation
2018;42(2):125-128
- CountryChina
- Language:Chinese
-
Abstract:
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.
