Introduction of the FAQ on IEC 62304 Over the Medical Software Development and Regulatory
SUN Zhuo-hui;CHEN Da-yu;NIU Jin-li;GE Healthcare;Philips (China Investment Co. Ltd.;
As software gaining it's importance in the application of medical devices, the corresponding standard IEC62304 become a very important basic standard. However, a lot of questions raised in the understanding and during the practice of this standard. Some frequent questions were collected by NB-Team, and the answers are organized as a document. As we expecting the document is quite valuable for the Chinese medical devices industry we introduced this FAQ and made an understanding of this document.