VCBeat (WeChat ID: vcbeat) has learnedOn January 16, 2018, MedCRO, a medical device contract research organization (CRO), announced the completion of its Series A financing round, raising tens of millions of RMB. The round was led by Honghui Capital, with Chongshan Capital participating as a co-investor. Reportedly, the funds will be primarily used to expand hospital resources and build up talent reserves.
MediSino, established in 2011, is a regulatory consulting firm specializing in medical device registration and filing, dedicated to providing enterprises withComprehensive One-Stop Solution for Medical Device Registration and Clinical Trials。
Service offerings include: product registration and filing, clinical trial research, design and execution of animal study protocols, manufacturing system consultancy, GMP facility design and construction, new product design, development, validation, and technology transfer, as well as metrology accreditation. Our specialty lies in registration and filing services and clinical trial research for Class III implantable medical devices.
It is reported that Medisino is currently the only CRO company in China that provides a full range of business services related to medical device registration.
The core team members are elite professionals from registration and clinical departments at leading domestic multinational corporations, manufacturers, and regulatory consulting firms. They possess in-depth expertise in the CFDA regulatory framework and submission processes, offering highly mature and professional medical device registration services.
Founder and CEO He Xiaochen previously served in the Marketing and Sales Department of Jietong Group, the leading CRO brand in the medical device sector, as well as in the Government Affairs Department of China Resources Wandong. With 10 years of experience in regulatory consulting for medical devices both domestically and internationally, he possesses profound knowledge and practical expertise in clinical trial research, animal testing, and medical device quality management systems.
Co-founder Dong Binzhe has 12 years of experience in medical device registration, testing, and clinical trial research, having participated in and guided the completion of over 600 medical device registration projects.
Through years of dedicated efforts and in-depth cultivation in the field of medical device registration,Medisun has currently provided high-quality services to well-known domestic and international enterprises such as Siemens, Olympus, Omron, Osstem, United Imaging, Weigao, Yuwell, and Kehua Bio-engineering, obtaining over 1,500 registration certificates for both domestically produced and imported medical devices.
Regarding this round of financing, Dr. Yan Jingran from Honghui Capital stated, “With the increasingly comprehensive regulation of medical devices, there is a growing need for more specialized and systematic talent to provide services to medical device companies. The MedThink team’s extensive and professional experience will play an even greater role in this field.”
Meanwhile, Yang Ying from Chongshan Capital stated, “The medical device CRO industry still presents significant opportunities for M&A and consolidation. Medisicre focuses on developing relationships with leading clients and innovative projects, rapidly enhancing its clinical trial service capabilities, and expanding upstream R&D capabilities to establish competitive barriers, thereby demonstrating strong potential for scaling and brand building.”