Oxford Instruments Healthcare Korean FDA Approval Refurbished GE CT Systems

September 22, 2014 — Oxford Instruments Healthcare, a division of Oxford Instruments that specializes in providing after-market GE computed tomography (CT) and magnetic resonance imaging (MRI) scanners, announced that it has recently received approval from the Korean Food and Drug Administration (KFDA) to import and market its refurbished GE CT equipment and parts to South Korea.

The news of approval from the KFDA marks another significant milestone in the company’s continued growth, by expanding its current market share with its approved portfolio of after-market medical devices and services. Steve Hong, CEO and owner of GMR Co., will continue to help Oxford Instruments Healthcare expand in South Korea by taking on the exclusive distributor rights of GE CT equipment and parts along with the current MRI equipment and parts.

“Receiving CT certification from the KFDA is an important milestone for our company’s growth in Asia and it secures our sales of high-quality refurbished equipment throughout South Korea,” said Robert Costa, director of global gales at Oxford Instruments Healthcare. 

In addition, the approval serves as a validation of the company’s commitment to maintaining a strict quality management system that adheres to multiple international standards, ranging from The International Organization for Standardization (ISO) to Korean Good Manufacturing Practices (KGMP) — ensuring high levels of excellence for all customers.

“Korea has strict guidelines for importing refurbished equipment. Therefore, in earning this approval, our customers in Korea can be confident that the products they purchase are controlled within a certified quality management system that is based on our mission to enhance customer satisfaction,” said Jeff Fall, president, Oxford Instruments Healthcare.

For more information: http://www.oxford-instruments.com/businesses/service/healthcare


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