McCarthy Avril D, Lawford Patricia V
a Medical Physics and Clinical Engineering .
b NIHR Devices for Dignity Healthcare Technology Co-operative at Sheffield Teaching Hospitals NHS Foundation Trust, Royal Hallamshire Hospital , Glossop Road , Sheffield , S10 2JF , UK .
J Med Eng Technol. 2014;39(7):441-7. doi: 10.3109/03091902.2015.1088087. Epub 2015 Sep 29.
The paper provides an introduction to the regulatory landscape affecting a particular category of medical technology, namely standalone software-sometimes referred to as 'software as a medical device'. To aid the reader's comprehension of an often complex area, six case studies are outlined and discussed before the paper continues to provide detail of how software with a medical purpose in its own right can potentially be classified as a medical device. The reader is provided an appreciation of how to go about classifying such software and references to support the developer new to the field in locating detailed regulatory support documents and contact points for advice.
本文介绍了影响某一特定类别的医疗技术（即独立软件，有时也称为“软件即医疗设备”）的监管环境。为帮助读者理解这一通常较为复杂的领域，本文概述并讨论了六个案例研究，然后继续详细说明具有医疗用途的软件本身如何有可能被归类为医疗设备。本文让读者了解如何对这类软件进行分类，并提供参考文献，以支持该领域的新手开发者查找详细的监管支持文件和咨询联系点。
