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BeyondDX Acquires International Standard Certification for 'ISO13485' in Development of Multi-Integrated Analysis Solutions

- In vitro diagnostic medical device research and development, manufacturing and quality management secured global level
- 'ForeCheck LC' to establish a bridgehead for domestic and global markets


Development of Multi-integrated Analysis Solution Beyond DX (CEO Chung So-jin) announced on the 28th that it has first certified ISO 13485:2016 (Medical devices-Quality Management Systems for Regulatory Purpose), an international medical device quality management system certification.

ISO 13485:2016 certification is an international standard certification that ensures that developers of in vitro diagnostic medical device manufacturing comply with the quality, safety and regulatory requirements of the product and, in particular, meets the required holding conditions for obtaining CE-IVDR certification, a European in vitro diagnostic device certification.

The scope of BeyondDX's ISO 13485:2016 certification includes the design, development, manufacturing, sales, and service of immunodiagnostic reagent products in the in vitro diagnostic medical device system. Through this certification, BeyondDX is fully prepared to prove its product quality level and advance into the global market.

Recently, regulations on in vitro diagnostic medical devices in the European Union have been continuously strengthened. In particular, it is essential to obtain European IVDR certification, so BeyondDX plans to preemptively acquire IVDR CE certification with domestic approval of "Forecheck LC", a medical device for early diagnosis of lung cancer, next year to expand exports in the European market.

"Based on our excellent technology and licensing capabilities, we will take a step forward in entering not only the domestic market but also the global market," said Jung So-jin, CEO of BeyondDX.