News Room

Notice

BeyondDx Obtains ISO13485:2016, International Medical device Quality Management System certification

2024-08-28 13:39:21

 

BeyondDX 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 their products, and in particular, is required for obtaining CE-IVDR certification, a European in vitro diagnostic device certification.

 

Through this certification, we are fully prepared to prove the quality of our products and enter the global market.