Located in Shanghai ZJ Innopark, Ezisurg Medical Co., Ltd. (Ezisurg Medical) is a high-tech company, specializing in the development and commercialization of high-end MIS devices for tumors. It is not only a national high-tech enterprise but also a brand-building demonstration institution of the Ministry of Industry and Information Technology of China (MIIT) and Shanghai Municipality.
In order to develop high-quality products and a high-end brand, Ezisurg Medical has established a quality management system strictly in accordance with ISO13485 and relevant regulations and instructions to conduct product lifecycle management. It has also built a high-level quality management team consisting of over 70 members, among whom the proportion of quality management personnel is far higher than the average level of the domestic medical device industry.
During the first unannounced inspection of medical device enterprises in China carried out by TÜV Rheinland, an EU Notified Body with the Conformité Européenne (CE) mark, Ezisurg Medical was listed among the first group of enterprises to be inspected and passed the test on the first try with a result of “0 finding”. Then during the CE review and certification expansion review, Ezisurg Medical passed the reviews again, both with a result of “0 finding”, showing its strong quality management.
Furthermore, Ezisurg Medical has won numerous relevant qualification certificates and honors. For example, in 2015, it passed the ISO13485 certification (Certificate No.: SX601054520001); its product easyEndo™ MIS stapler was recognized as Good Chinese Technology by the China Association of Productivity Promotion Centers and was included in the China Torch Program of the Ministry of Science and Technology of China. In 2016, its easyEndo™ Universal Linear Cutting Stapler won the Silver Innovation Award at the 18th China International Industry Fair, and the company was selected as a brand-building demonstration institution of Shanghai. In 2017, its new production site and certificate renewal passed the ISO13485: 2016 certification (Certificate No.: SX601227580001); it won the “Top 10 Popular Projects” award at the 5th China (Shanghai) International Technology Fair and was awarded 2017 Top Brand of Shanghai; it was selected as a member of the fifth group of brand-building demonstration institutions by the MIIT. Ezisurg Medical was also honored as a “Shanghai Outstanding Brand Building Enterprise” by the Shanghai Association for Quality and Shanghai Light Industry Sci & Tech Intelligence Institute; its two products “easyEndo™ Universal Linear Cutting Stapler and Loading Units” and “easyEndo™ Linear Cutting Stapler and Loading Units” were included into 2017 Shanghai Recommended List for Innovative Products; it obtained Pudong New Area funding for popular science projects (project name: Popular Science Development for Innovative Outcomes of Minimally Invasive Surgery for Tumors); and it was also listed among “New, Specialized, Sophisticated, Distinctive” Small and Medium-Sized Enterprises in Shanghai.
Upholding the concept of “Efficiency, Learning, Innovation and Benefits”, Ezisurg Medical has been committed to building itself into a high-end MIS brand in China, with the objective of “taking a leadership role as a provider of MIS devices in China, and becoming a competitive player by exerting significant influence on the global market”.