Analysis of Field Inspection Issues and Some Suggestions for Software as Medical Device

With the encouragement of policies and the rapid development of the biopharmaceutical industry, the number of software as medical device (SaMD) registration applications in Shanghai has continued to increase in recent years, and this paper summarizes the GMP nonconformities found in the field inspec...

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Bibliographic Details
Main Authors: Yiqiang YANG, Zhijin FAN, Shuting GUO
Format: Article
Language:zho
Published: Editorial Office of Chinese Journal of Medical Instrumentation 2024-05-01
Series:Zhongguo yiliao qixie zazhi
Subjects:
Online Access:https://zgylqxzz.xml-journal.net/article/doi/10.12455/j.issn.1671-7104.230639
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