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.
Subject(s)
Commerce , Magnetic Resonance ImagingABSTRACT
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.
Subject(s)
Humans , Equipment Design , Magnetic Resonance Imaging , Positron-Emission TomographyABSTRACT
In recent years, the R&D and production level for Computed Tomography(short for CT) have been greatly improved and developed in China. In fact, it leads to higher requirements for medical device regulators. In order to clear key points in field inspection for regulators, this article analyzes the risk prevention and control points in the production process of CT based on the 5M1E analysis, and combined with medical device good manufacturing practice (short for GMP), presents exploratively some suggestions on the field inspection of CT manufacturers. This article also has important sense for regulators to clear the pertinence and improve the efficiency during the field inspection.