Analysis of Risk in Production for PET/MR and Suggestions for Field Inspection.
10.3969/j.issn.1671-7104.2019.05.015
- Author:
Yiqiang YANG
1
;
Xin LIU
1
;
Hong QIAN
1
Author Information
1. Center for Certification & Evaluation, SHFDA, Shanghai,
- Publication Type:Journal Article
- Keywords:
GMP;
PET/MR;
field inspection;
risk prevention and control
- MeSH:
Equipment Design;
Humans;
Magnetic Resonance Imaging;
instrumentation;
Positron-Emission Tomography;
instrumentation
- From:
Chinese Journal of Medical Instrumentation
2019;43(5):365-368
- CountryChina
- Language:Chinese
-
Abstract:
PET/MR is a high-end medical imaging equipment with integrating PET and MR equipment into the highly sophisticated one and has rich clinical and molecular diagnosis functions, can obtain comprehensive information about the human body structure, function and metabolism, is of great value for the diagnosis and treatment of disease improvement. In this paper, through the analysis of existing production risk points on one of the primary stages of the whole product life cycle, combining with the medical device good manufacture practice, some suggestions have been put forward exploratively to field inspection for PET/MR manufacturers. It has certain significance for regulators of medical devices to clear the production risk point and improve verification efficiency during field inspection.
