关于移动医疗器械监管的探讨
관우이동의료기계감관적탐토
Consideration of Mobile Medical Device Regulation
  • 万方数据
    中国医疗器械杂志 중국의료기계잡지
    CHINESE JOURNAL OF MEDICAL INSTRUMENTATION
    2015年 4期 272-274 ,共3页

    彭亮%杨鹏飞%贺伟罡

    팽량%양붕비%하위강

    移动医疗器械%移动医疗应用%监管%风险 移動醫療器械%移動醫療應用%鑑管%風險
    이동의료기계%이동의료응용%감관%풍험
    mobile medical device%mobile medical application%regulation%risk
    移动医疗器械的监管是当前业内关注的热点之一。结合移动计算技术和美国FDA移动医疗应用指南，分析讨论了移动医疗器械的定义、监管范围与要求、潜在风险。我国移动医疗器械的监管工作需要采用基于风险的方法。
    이동의료기계적감관시당전업내관주적열점지일。결합이동계산기술화미국FDA이동의료응용지남，분석토론료이동의료기계적정의、감관범위여요구、잠재풍험。아국이동의료기계적감관공작수요채용기우풍험적방법。
    The regulation of mobile medical devices is one of the hot topics in the industry now. The definition, regulation scope and requirements, potential risks of mobile medical devices were analyzed and discussed based on mobile computing techniques and the FDA guidance of mobile medical applications. The regulation work of mobile medical devices in China needs to adopt the risk-based method.
    원문보기 원문다운로드 사이트로이동
저자의 최근 논문