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Group History  ■ Shanghai Mid-Link Consulting Co., Ltd. was founded by Hong Xiaoming and Fu Li.
■ Completed registration of the 100th medical device product with the U.S. FDA. ■ Became the consulting corporate with the highest number of medical device submissions and completed registrations to the U.S. FDA each year worldwide. ■ Mid-Link Technology Testing Co., Ltd. was established.
■ Official opening of Mid-Link Technology Testing in January. ■ Obtained the ISO 17025 certificate issued by the ANAB in March. The reprocessing testing for reusable medical devices is an exclusive test item in China. ■ The company achieved profitability in the same year. ■ Passed the two-in-one audit by CNAS and national CMA, and became the first private medical device testing organization in China that had obtained CMA. ■ Accessed authorization for the validation testing for atypical sterilization methods, which an exclusive test item in China. ■Was selected as one of the first batch of strategic emerging enterprises in Tianjin. ■ Was entrusted to form the third-party testing branch of China Association for Medical Devices Industry, and became the secretariat unit. ■ Accessed authorization for biological evaluation of medical devices containing respiratory lines, which is an exclusive test item in China. ■ Participated in the working group of Guidelines for the Reprocessing of Reusable Medical Devices of the NMPA as the only private medical device testing organization. ■ Was selected as one of the technology-leading enterprises in Tianjin and awarded the title of national high-tech enterprise. ■ Completed several training sessions on compliance of epidemic-related products to domestic and international markets under the commission from the marketing and medical products administrations. ■ Completed emergency approvals for almost 100 epidemic-related medical devices in China, the U.S., Canada and the EU. ■ Integrated four companies into Mid-Link Biomedical Technology Group and started the 5-year listing plan of the Group. ■ Extended a 7,200 m2 medical device and drug testing center in the Economic Development Zone.
■ Completed the new headquarters of Mid-Link Consulting in Hedong District, Tianjin. ■ Passed the OECD GLP on-site audit without any defect, becoming the only testing organization accredited jointly by national CMA, CNAS, ANAB, FDA GLP and OECD GLP in China. ■ Completed Series A financing of approximately 100 million yuan, the largest single round of financing in the medical device CRO field |
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