It was selected as a support project for the usability test for FDA certification by the Ministry of SMEs and Startups and received government support of 100 million won.

When a new medical device is developed, the user (nurse, medical staff) accepts the opinions of users derived from the formative and formative tests, which are tests before the final development, whether it is suitable for use by users (nurse, medical staff), and reports through a summative evaluation test as the final product. After applying for a base certification and being audited, a certification is issued.

In principle, the uasbility test for FDA certification is conducted in the United States. For FDA certification, Seoul National University Hospital's usability test lab was established for the first time in Korea through a support project for the Korea Health Industry Development Institute. As it was not recognized by the US FDA, we decided to proceed with FDA certification by conducting a summative test at a testing institution in the US under the supervision of Seoul National University Hospital.

The management agency is Korea Testing & Research Institute and the agreement period is from July 14, 2020 to July 13, 2022.

If there are no special problems, it is expected to receive FDA certification for Anyfusion in the second half of next year, and if it is certified, we will proceed more actively to enter the US. If Anyfusion H100 pump is FDA-certified, it is expected that US approval and market entry for applied products such as blood pump, automatic anticancer drug equipment, and PCA pump will be accelerated.

Thank you.