Analysis of Risk in Production for PET/MR and Suggestions for Field Inspection / 中国医疗器械杂志
Chinese Journal of Medical Instrumentation
;
(6): 365-368, 2019.
Artículo
en Chino
| WPRIM
| ID: wpr-772483
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.
Texto completo:
Disponible
Índice:
WPRIM (Pacífico Occidental)
Asunto principal:
Imagen por Resonancia Magnética
/
Tomografía de Emisión de Positrones
/
Diseño de Equipo
Tipo de estudio:
Estudio de etiología
Límite:
Humanos
Idioma:
Chino
Revista:
Chinese Journal of Medical Instrumentation
Año:
2019
Tipo del documento:
Artículo
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