Coreline Soft Obtains 'MDSAP' Certification for Single Audit in 5 Major Countries Including the US and Japan

[Asia Economy Reporter Lee Gwanju] Medical AI solution company Coreline Soft announced on the 24th that it has obtained certification for the Medical Device Single Audit Program (MDSAP), a medical device single audit program involving five countries: the United States, Canada, Japan, Australia, and Brazil.

MDSAP is a system established by the International Medical Device Regulators Forum (IMDRF) that certifies medical devices meeting safety and quality management standards through a single audit of medical device manufacturing facilities.

Once certified, manufacturers receive benefits such as full or partial exemption from certification audits of manufacturing facilities by regulatory agencies in the five countries?United States, Canada, Japan, Australia, and Brazil?and the certification is valid for three years.

With this certification, Coreline Soft can save time and costs previously spent on individual country product approval procedures while also proving the credibility of its product quality. MDSAP-certified companies are recognized for their quality management capabilities to the extent that the U.S. Food and Drug Administration (FDA) exempts on-site inspections of manufacturing facilities.

Kim Jin-guk, CEO of Coreline Soft, said, "We have been internationally recognized for excellence in managing all stages of medical device development, from product development processes to production and post-sales management," adding, "As a medical AI company differentiated from leading global competitors, we will devote our efforts to overseas markets."

Coreline Soft has obtained approvals from the U.S. FDA, European CE, Japan PMDA, and Taiwan TFDA, and was the first overseas AI company to receive approval in Taiwan. Recently, it has been accelerating its entry into the global diagnostic market by consecutively winning lung cancer screening projects in major countries such as Germany, the Netherlands, and Italy. It also plans to initiate the KOSDAQ listing process within the first half of this year.