Others include that of a British cardiologist, Peter Wilmshurst, who criticised the safety of an American-made medicaldevice at an American conference-but is being sued, personally, in England.
The organization shall determine the significance of the change to function, performance, usability, safety and applicable regulatory requirements for the medicaldevice and its intended use.
组织应当确定医疗器械的功能、操作、可用性、安全性和适当的法规要求和它的预期用途变更的重要性。
3
Conclusion Strengthen the rational use of medical equipment to ensure the safety of medicaldevice.