Coreline Soft Obtains 'World's Highest AI International Standard Certification'

Coreline Soft announced on April 29 that it has obtained certification for ISO/IEC 42001, the international standard for artificial intelligence (AI) management systems. This marks the first time a Korean medical AI company has secured ISO/IEC 42001 certification. Coreline Soft plans to accelerate its expansion into global markets such as the United States and Europe, using the acquisition of this international AI standard as a launchpad.

ISO/IEC 42001, established in December 2023, is the world’s first international standard for AI governance. It sets forth requirements for ethics, fairness, transparency, accountability, risk management, and personal data protection in the development and operation of AI systems. The certification process is known for its rigor, as it requires full compliance with all 27 assessment criteria for AI systems.

Coreline Soft aims to accelerate its entry into advanced global markets, focusing on the United States and Europe, following this certification. In these regions, medical AI and clinical decision support systems (CDSS) are subject to strict evaluations regarding data reliability and algorithmic fairness. Coreline Soft has already proven the performance of its AI products through U.S. Food and Drug Administration (FDA) and European CE certifications, and has also completed AI data compliance verification under HIPAA and GDPR regulations.

In particular, Coreline Soft’s position in its key market, Europe, is expected to be further strengthened. The European Union (EU) signaled strict regulations on high-risk AI systems through the ‘EU AI Act’ announced last year. Since ISO/IEC 42001 can only be obtained by meeting the stringent requirements set by the EU, the company explained that this will enable it to maximize its market share in Europe going forward.

A Coreline Soft representative stated, “Being the first Korean AI medical device company to acquire international AI standard certification once again demonstrates Coreline Soft’s AI technology leadership, not only domestically but also in the global market.” The representative added, “Having proven our world-class AI technology in international academic journals, we will further strengthen our market dominance in the U.S. and European markets, where medical AI regulations are particularly strict, following this international AI standard certification.”

He continued, “With this international standard certification, we expect to expand not only government contracts worldwide but also new supplies to major overseas medical institutions. In particular, multinational hospitals and medical device companies have stringent requirements for both AI performance and safety, so if adopted, long-term exclusive supply is expected to be possible.”