磁共振成像(MRI)设备生产环节风险点分析及现场质量体系核查建议

      Analysis of Risk in Production of MRI and Some Suggestions for Field Inspection

      • 摘要: 近年来,随着磁共振成像设备在临床上广泛应用,由于设备质量问题造成不良事件也时有发生,对制造商带来了压力,同时对医疗器械监管人员提出了较高的要求。为帮助医疗器械监管人员明确核查要点,按照医疗器械生产质量管理规范的要求,从产品生产要素出发分析了产品生产环节的主要风险点,提出了现场核查建议,对于提高核查效率具有现实意义。

         

        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.

         

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