MDSAP Certification

Date : 2025-05-22

•  Accelerating Global Expansion in the Medical Robotics Market by Enhancing Product Credibility and Regulatory Efficiency



CUREXO, a medical robotics company led by CEO Jae-Jun Lee, announced on the 21st that it has obtained MDSAP (Medical Device Single Audit Program) certification, which integrates regulatory audits for five major countries : the United States, Canada, Japan, Australia, and Brazil.


MDSAP allows medical device manufacturers to undergo a single regulatory audit that satisfies the quality management requirements of all five participating countries. This certification significantly streamlines the approval process, as it can replace or reduce the need for individual audits in each country.


With the MDSAP certification, CUREXO has not only strengthened the credibility of its product quality but also reduced the time and cost required for obtaining regulatory approvals in each target market. The certification is expected to serve as a critical turning point in the company's efforts to expand strategically into global markets.


A CUREXO official stated, "We are continuously expanding regulatory approvals across key global markets. The MDSAP certification will not only support our entry into new export regions but also enhance trust among our international partners."


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