心磁图仪注册技术审评探讨

      Discussion on Technical Evaluation of Magnetocardiography

      • 摘要: 心磁图仪产品的研发在国内外无相应的产品标准、行业标准可参考。该文从心磁图仪的工作原理和临床使用功能出发,以医疗器械注册相关法规和规范性文件为依据,提出该类产品技术审评若干思考和关注点。

         

        Abstract: There is no corresponding product standard and industry standard for the search and development of magnetocardiograph at home and abroad. In this paper, based on the working principle and clinical application function of magnetocardiograph, and on the basis of relevant regulations and normative documents of medical device registration, some thoughts and concerns about the technical review of this kind of product are put forward.

         

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