DNV supports NOUL in IVDR certification for AI-based medical diagnostic products
South Korea, Jan. 13 -- DNV, the independent global assurance and risk management provider, is partnering with Korean AI-driven blood and cancer diagnostics company Noul to certify their malaria diagnosis, blood cell morphology and cervical cancer testing solutions, under the European Union's In Vitro Diagnostic Medical Device Regulation (IVDR).The EU's IVDR provides a regulatory basis for establishing the safety and effectiveness of new in-vitro diagnostic (IVD) devices. Most IVD devices require a certificate of compliance with the IVDR to receive a CE mark that allows their sale in the EU. However, many other countries also recognize the CE mark as sufficient to market IVD devices, making IVDR compliance a gateway to global market access....
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