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Obtaining In-vitro diagnostic medical device manufacturing and quality control standards compliance

2024-12-09 15:08:20

BeyondDX, a multi-integrated analysis solution development company, will enter the cancer screening market in earnest. It has been recognized that the GMP manufacturing plant at 60 Haan-ro, Gwangmyeong-si, Gyeonggi-do, 1506 C-dong, 1507 meets the in vitro diagnostic medical device manufacturing and quality standards (GMP) after being reviewed by the Korea Institute of Industrial Technology (KTL) and the Ministry of Food and Drug Safety.

In addition to the ISO 13485:2016 international standards acquired in August, we have secured facilities in accordance with the Enforcement Rules of the In vitro Diagnostic Medical Device Act and production infrastructure that meets domestic and international standards of manufacturing and quality management systems.

BeyondDX will show examples of establishing commercialization partnerships with ForeCheck LC's domestic and foreign licenses based on proven production/development infrastructure, and will work hard to expand to global markets such as Europe and the United States.