Release date: 2014-12-03
European patients implanted with three types of medical devices in China, which was almost impossible in the past, has now been done by a Shenzhen company. Recently, Medtronic, the world's leading medical technology company, ordered the first CeraFlex occluder from Xianjian Technology and sold it to more than 20 mainstream Western countries including the UK, Germany, Italy and France. This means that domestic high-end medical devices entered the mainstream market of Western medical devices for the first time, and Chinese medical devices have entered China's creation from Chinese manufacturing.
CeraFlex is a high-end precision medical device for the treatment of atrial septal defect (VSD), ventricular septal defect (ASD), patent ductus arteriosus (PDA) shunt congenital heart disease, suitable for the implantation of infants with congenital heart disease. As the highest risk grade medical device, the CeraFlex series has been approved by the European Union in 2011, obtained the CE certificate, and has fully met the EU standards in use. Zhao Yiwei, executive director and CEO of Xianjian Technology, said that after two years, Xianjian Technology invested nearly RMB 50 million to improve the quality management system and registration documents; optimize test methods; improve processes and strengthen various trainings; A qualitative leap in the operation and quality system. From standardization processes to employee skills certification, quality awareness, process management science control, improvement and preventive measures, and continuous quality improvement, we are close to the requirements of world-class companies. It is hoped that Xianjian Technology will become the first Chinese brand to enter the mainstream market of Western medical devices. It will serve as a reference for the globalization of celebrity enterprises, and take this opportunity to lead the industry to high-tech, world-class quality and globalization. In the direction of progress, China has emerged a batch of outstanding enterprises.
Source: CFDA
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