With many years of experience in medical device regulations, I possess extensive expertise in the registration and filing of medical devices and in vitro diagnostic reagents, obtaining production and supply licenses and filing certificates, registering food safety test reagents, and establishing as well as maintaining production quality management systems. I have particularly strong experience in the operation and management of clinical trials. I am well-versed in the entire pre-market product launch process, including project planning, R&D process management, registration applications, clinical evaluations, quality system establishment and maintenance, intellectual property management, patent applications, and applications for project funding. I also have hands-on experience in biological laboratory work. Looking ahead, I will continue to deepen my expertise in medical device regulations to accelerate the successful market entry of new products.