可穿戴医疗设备的监管。
The Regulation of Wearable Medical Devices.
机构信息
School of Engineering and Applied Sciences, Harvard University, Cambridge, MA 02138, USA.
Department of Chemical Engineering, Imperial College London, London SW7 2AZ, UK.
出版信息
Trends Biotechnol. 2020 Feb;38(2):129-133. doi: 10.1016/j.tibtech.2019.06.004. Epub 2019 Jul 15.
This article provides a guideline for the design, manufacture, regulatory approval, and post-market surveillance (PMS) of wearable medical devices (WMDs). The integration of regulatory considerations can accelerate wearable device (WD) development from laboratory to market while mitigating device failure risks. The implementation of stringent clinical evaluations will transcend WDs beyond consumer products.
本文为可穿戴医疗器械（WMD）的设计、制造、监管审批和上市后监测（PMS）提供了指导方针。将监管考虑因素整合在一起，可以在降低设备故障风险的同时，加快可穿戴设备（WD）从实验室到市场的开发速度。严格的临床评估的实施将使 WD 超越消费品。
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