Meets Common Quality Standards Across Five Participating Countries, Strengthening Foundation for Global Business Expansion

[April 2, 2026] AITRICS, a medical artificial intelligence (AI) company, announced on April 2 that it has obtained certification under the Medical Device Single Audit Program(MDSAP).

MDSAP is an international medical device audit program involving five participating countries — the United States, Canada, Japan, Brazil, and Australia — that evaluates the quality management systems of medical device manufacturing facilities against internationally recognized standards.

Through this program, companies seeking to market medical devices in multiple countries can undergo a single audit covering both common quality management requirements and country-specific regulatory requirements. Obtaining MDSAP certification helps reduce the burden of repetitive quality audits previously required by individual countries.

With this certification, AITRICS has been recognized as meeting the quality standards required by all five participating countries. Based on this achievement, the company has further strengthened its quality and regulatory readiness for global market expansion and expects to reduce the time and cost associated with country-specific regulatory approval processes.

The certification is particularly meaningful in that it objectively demonstrates that AITRICS-VC (VitalCare), the company’s AI solution for predicting patient deterioration, is supported by a globally aligned quality management system. This is expected to have a positive impact on the company’s entry into major global markets.

Kwangjoon Kim, CEO of AITRICS, stated, “This certification is a significant achievement that demonstrates our ability to meet the stringent quality standards of five major countries simultaneously, underscoring our global competitiveness in quality and marking an important milestone in our global expansion”, said “Building on this accomplishment, we will continue to accelerate our overseas expansion based on a quality management system that meets international standards and focus on delivering reliable services in clinical settings”.

AITRICS-VC(VitalCare) is currently in use at more than 170 medical institutions in Korea, including tertiary general hospitals. The solution has also received U.S. FDA 510(k) clearance and completed local regulatory approvals in Vietnam and Hong Kong. In addition, AITRICS continues to expand its global business network through the establishment of local entities in the United States and Japan.