Medical Device Certification Articles & Analysis
5 articles found
Food & Drug Administration (FDA) quotes the International Medical Device Regulatory Forum’s definition: "software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device." ...
The systems used for this are powerful flushing/suction devices equipped with motors, circuit boards, copper wires and other technical components that are powered by several batteries. After the suction process, i.e. after just a few minutes, the devices are disposed of again. As hazardous waste, of course, after all it is a mixture of plastic, electronic waste ...
We’d like to give you a few tips on how to choose an effective baby nasal aspirator that guarantees safety, focusing primarily on adequate suction power. Let’s go! A certified medical device It is worth paying attention to whether the nasal aspirator has a medical device certificate or not, as ...
ByNosiboo
It is an undeniable fact that safety and quality are the top-most priority for medical device companies. However, the best-practices to maintain these priorities are defined under ISO 13485. You cannot brush aside the need for implementing the right enterprise quality management software to create and maintain the culture of quality and continuous improvements. The software may help you meet ...
At the beginning of Chinese New Year, Beijing Yaguo Technology Co., Ltd.'s innovative medical device "Respiratory Power" respiratory neuromuscular stimulator was officially launched. "Respiratory power" has been established in 2015 as a core innovative product of Yaguo, Through 4 years of continuously efforts, after research, demonstration, design, development, ...