Analysis of Risk in Production of MRI and Some Suggestions for Field Inspection.
10.3969/j.issn.1671-7104.2021.05.015
- Author:
Yongzhang LIU
1
;
Yiqiang YANG
1
Author Information
1. Shanghai Medical Device and Cosmetic Evaluation and Verification Center, Shanghai, 200020.
- Publication Type:Journal Article
- Keywords:
GMP;
MRI;
analysis of risk;
field inspection
- MeSH:
Commerce;
Magnetic Resonance Imaging
- From:
Chinese Journal of Medical Instrumentation
2021;45(5):542-545
- CountryChina
- Language:Chinese
-
Abstract:
In recent years, with the wide application of magnetic resonance imaging (MRI) equipment in clinical practice, the quality of the equipment causes adverse events, which put pressure on manufacturers, at the same time, it puts forward higher requirements for medical device supervisors. In order to help the medical device supervisors to clarify the key points of verification, this paper analyzes the main risk points in the production process of the product according to the medical device good manufacturing practice(GMP), and puts forward the suggestions for field verification, which has practical significance for the submission of verification efficiency.
