Shanghai, China – From October 10 to October 11, Shanghai MicroPort Medical (Group) Co., Ltd. ("MicroPort®") hosted "Shanghai Municipal Food and Drug Administration Medical Device Inspector Training Base – Training on Technology Assurance of Medical Device Sterility", which kicked off series of activities focused on the importance of quality that will last through the end of October. These series of activities are designed to enhance the quality system within the company in response to the call of the government and President Xi Jinping on quality improvement.
The training was sponsored by Shanghai Municipal Food and Drug Administration and organized by Special Committee of Medical Device Package of China Association for Medical Device Industry. Yong Li, Vice President of Corporate QA&QC of MicroPort®, chaired the opening ceremony of the training. Senyong Lin, Director of Shanghai Municipal Food and Drug Administration Medical Device Supervision Department and Board Member Representative of Medical Device Package Special Committee of Chinese Medical Device Industry Association, Min Wu, Marketing Manager of DuPont Asia-Pacific, and Yimin Xu, Executive Vice President of Regulatory Affairs & Property Management of MicroPort®, delivered speeches respectively representing government authorities, associations and companies, to express the common aspiration of promoting the development of China's medical device industry with joint effort. The training is fully supported by Shanghai Municipal Food and Drug Administration, and attracted over 80 attendees from Shanghai Municipal Food and Drug Administration Certification and Review Center, Pudong New Area Market Supervision and Administration, Xuhui District Market Supervision and Administration, Yangpu District Market Supervision and Administration, and Shanghai Testing & Inspection Institute for Medical Devices.
MicroPort® has been appointed as the Training Base of Implantable and Interventional Medical Device Inspector since 2016 by Shanghai Municipal Food and Drug Administration responsible for organizing training courses related with implantable and interventional medical device inspection in the hope of cultivating professional medical device inspectors. The training focusing on "Technology Assurance of Medical Device Sterility" covers topics including ethylene oxide sterilization technologies, irradiation sterilization technology, aseptic packaging technology, microbiological inspection technology, as well as control technology integration of clarification system and the water and the gas consumption, in two-day lectures by industry experts from JPY, DuPont China, TÜV SÜD, and Sterigenics International LLC. In particular, Senyong Lin's course on "plans and challenges of medical device supervision in the age of innovation" pointed out a new direction for the operating mode of future medical device supervision, offering inspirations for industry peers.
"Quality" ranks the top of MicroPort®'s eight core values. MicroPort® has established a quality management system in accordance with the China Food and Drug Administration ("CFDA") regulations, and have obtained ISO 13485 certificates for the design, development, production and distribution of most of the products we currently offer. Also, the company successfully passed on-site audit of CFDA and other counterpart authorities of European Union, Japan and etc., and has received certification from third-part institutions such as DEKRA for its system and products to ensure the product quality is strictly controlled during its life span. MicroPort®'s core value and competitiveness result from high-quality, reliable, delicate and cost-effective products and impressive customer service. MicroPort® employees are always enthusiastic and passionate about maintaining the highest standards of quality in all aspects of daily operation of our business. The pursuit of excellence has been deeply rooted in our corporate culture. MicroPort® employees hold the motto that "I am deadly serious about my work as I know every single product of ours touches a life and any negligence on my part may bring a patient to the verge of life and death."