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September 18, 2017

BSI Awarded NEXCOM with ISO 13485:2016 Certification of Quality Management Systems for Medical Devices

「ISO 13485醫療器材品質管理系統」驗證證書

NEXCOM has announced, once again, it will be tackling one of the world's biggest vertical markets using its industry 4.0 expertise, the healthcare industry. In August of 2017, British Standard Institute (BSI) awarded NEXCOM's Taipei factory with the ISO 13485:2016 certification for quality management systems for medical devices for regulatory purposes. With this certification, NEXCOM is officially ready to jump into the healthcare industry.


According to the National Health Insurance Administration of Taiwan, the number of treated hemodialysis cases in 2016 reached a staggering 77,030 and the number is still rising. To increase the overall quality of medical care, solutions must focus on improving one of most critical aspects of patient care, how to seamlessly and economically transfer patient's medical profiles from one medical institution to another.


In 2015, NEXCOM United International Co., Ltd. was established in Shanghai with the primary focus on providing an intelligent medical information management system using internet of things to digitally process patient data and store them on to cloud. NEXCOM's extensive experience in hardware R&D within the IPC industry allowed for easy integration with sophisticated medical software, currently, used in the healthcare industry.


NEXCOM United has already brought to market a complete intelligent medical information management solution designed, specifically, for hemodialysis treatment centres called, FC 365. The main objectives of FC 365 are to decrease facility congestion and to reduce human errors in data collection. FC 365 can minimize human errors as the tedious process of handwriting medical profiles comes with high degrees of penmanship mistakes which have been studied to have negative impacts on the overall quality of medical care received by patients.




NEXCOM United is already a leader in the Chinese healthcare industry with over 550 successful hemodialysis cases reported from the implementation of FC 365 in primary-level hospitals in Beijing, Shanghai, and SuZhou. For the upcoming year, NEXCOM United intends to partner with hundreds of secondary-level hospitals to set another new record of successful hemodialysis cases.

NEXCOM Group – Introduction to NEXCOM United International Co., Ltd.

Established in July 2015, Shanghai, NEXCOM United International Co., Ltd. is a subsidiary company of NEXCOM International Co., Ltd. The main business of NEXCOM United is to provide hospitals with intelligent management solutions by joining software with firmware designed, specially, for the healthcare industry. The sales, R&D, and purchasing departments at NEXCOM United serves their customers with the greatest standard of professional expertise, technology, after-sales service, product quality and supply chain management. Under NEXCOM's impressive management, NEXCOM United ensures all three departments are at its optimal productivity level to help their customers achieve their vision.



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