AITRICS, a medical artificial intelligence (AI) company, announced on Thursday that it has obtained certification for the Medical Device Single Audit Program (MDSAP).
MDSAP is an international medical device auditing system involving five countries: the U.S., Canada, Japan, Brazil, and Australia. The program evaluates the quality management systems of medical device manufacturing facilities according to global standards. This allows companies seeking to sell medical devices in multiple countries to undergo a single, comprehensive quality management assessment. By obtaining this certification, companies can significantly reduce the burden of repetitive quality audits in different countries.
With this certification, AITRICS has demonstrated compliance with the quality standards of all five participating countries. This achievement strengthens the company’s foundation for addressing quality and regulatory requirements necessary for global market entry, while also reducing the time and costs associated with national approval processes.
AITRICS emphasized the importance of this certification, stating that it objectively demonstrates the application of a globally recognized quality management system to its AI solution for predicting patient deterioration, AITRICS-VC (VitalCare). The company expects this certification to positively impact its entry into key global markets.
VitalCare is currently implemented in over 170 medical institutions across South Korea, including advanced general hospitals. The solution has received U.S. Food and Drug Administration (FDA) 510(k) clearance and local approvals in Vietnam and Hong Kong. AITRICS is expanding its global presence by establishing subsidiaries in the U.S. and Japan.
Chief Executive Officer (CEO) Kim Kwang-jun stated that this certification is a significant achievement that demonstrates the international quality competitiveness by simultaneously meeting the stringent standards of five major countries. It marks a crucial milestone in our global expansion. He added that it will leverage this certification to accelerate the entry into overseas markets, focusing on providing reliable services in clinical settings while maintaining a quality management system that meets international standards.