DRGEM Achieves MDSAP Certification, Accelerating Global Expansion

DRGEM, a leading manufacturer of medical X-ray equipment, achieved a significant milestone this month by obtaining the Medical Device Single Audit Program (MDSAP) certification.

The MDSAP is an internationally recognized certification that demonstrates compliance with regulatory requirements in five major markets: Canada, the United States, Japan, Brazil, and Australia.

Built on the ISO 13485:2016 standard, MDSAP enables medical device manufacturers to streamline regulatory compliance through a single audit process in all five participating countries.

With the acquisition of MDSAP certification, the company anticipates gaining further momentum in its market expansion.

“This certification validates DRGEM’s dedication to maintaining world-class quality standards and ensuring operational excellence in its quality management system including manufacturing facilities,” said Sung-Hee Park, chief of the quality management department.

“We are thrilled to offer our global distribution partners even greater assurance in our compliance and capabilities.”

By focusing on product excellence, ease of use, and competitive pricing, DRGEM aims to solidify its presence as a trusted partner in the global medical imaging industry.