Founded in 1985, Changzhou Xin Neng Yuan Medical Stapler Co., Ltd. is a specialized manufacturer that integrates the research, manufacture and sales of medical devices including anastomosis staplers and suturing staplers.

Hardware facilities – Located in Zhonglou Economic Development Zone in Changzhou, Jiangsu Province, the company embraces 8,800m2 modernized standard plant buildings, including 10,000m2 workshop with Class 100,000 clean room environment conditions. The advanced production facilities presently equipped by the company include computer-controlled plastic injection molding machine, ultrasonic plastic welder, ultrasonic cleaner, purified water making equipment, shrink-wrap heat sealing machine, CNC milling machine, CNC lathe, precision drilling machine, etc. It is provided with a complete line of devices for physical, chemical and biological tests as can be witnessed by the series testing equipment in the test center, which include analytical balance, UV visible spectrophotometer, Rockwell hardness tester, digital display acidometer, pressure tester, germs collector, sterile package sealing strength tester, microcomputer mould incubator, etc. All tests that cover the full lifecycle of the product can be completed. The hardware facilities comply with the requirements for CE certification.     

Human resources – The company is presently staffed by 165 employees, of which 50 people have the education above college level, accounting for 30% of the total headcount; the technical staff have the professional knowledge and design capability relevant to medical devices and the managerial personnel are experienced with the special management for production and business operation in relation to medical devices. All of them have received training concerning quality management standards. The company attaches importance to employee development by establishing a complete system for general development of employees based on training, appraisal and application. The employees are provided with a pluralistic development path that may lead to career opportunities relating to technical personnel or technicians, even up to the management level.      

Technical innovation – The unremitting technical innovation has been rewarded with rich fruits time and again. The reusable medical alimentary canal anastomosis (suturing) stapler was listed in the Plan for Trial Production and Appraisal of State-level Important New Products in 1993. The disposable alimentary canal anastomosis stapler, which pioneered in China and possessed independent intellectual property right, was granted the medical device registration license from the State Administration in 2000. The PPH surgical instrument with independent intellectual property right, i.e. the series product including straight tubular anal hemorrhoid stapler, was researched and developed in 2002 to initiate the gradual replacement of imported staplers with China-made staplers. The company pays attention to the protection of intellectual property rights. Up to now, 42 patent applications have been filed, for which 39 patent rights have been awarded to cover 1 patent for invention and 38 patents for utility model.       

Quality management – The company started the establishment of quality management system in 2000 in accordance with the standards ISO9001 and YY/T0287. By applying the advanced Class-A management mode and implementing quality responsibility system at different levels, the company adheres to the quality policy of “meticulous design, diligent manufacture, honest management and assured application”. The company was granted with the YY/T0287-ISO13485 Quality System Appraisal Certificate from Jiangsu Provincial FDA and awarded the title of Good-Faith Unit of Medical Device Enterprises in Jiangsu Province in 2005-2006. Since 2007, the company has established the quality management system in accordance with the standards ISO9001 and ISO13485 as well as the requirements of MDD93/42/EEC for CE-certification of the products. Therefore, the quality management level has been upgraded continuously to ensure that the product quality management is implement throughout the whole process of product manufacturing.       

Customer service – The company as the pioneer in the market of domestic-made staplers in China has distributed its products in more than 40,000 medical institutions all over the country. The company has established its service brand that combines both marketing and service. Customer service is provided over the full lifecycle of the product. By implementing the whole-process follow-up and in-time quality information feedback for the instrument, hospitals and users are assured for use without any worry. Up to now, this company has contracted with more than 80 business companies to establish a complete network for marketing and service throughout the country in a bid to provide high quality services in a timely and efficient manner.