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News

KORU Medical Systems Announces Successful Appeal In EU Notified Body Review

Author: Benzinga Newsdesk | April 11, 2024 04:08pm

KORU Medical Systems, Inc. (NASDAQ:KRMD) ("KORU Medical" or the "Company"), a leading medical technology company focused on development, manufacturing, and commercialization of innovative and patient-centric large volume subcutaneous infusion solutions, today announced a successful appeal related to an ongoing audit by its notified body in the EU, The British Standards Institute (BSI).

The Company's appeal of an assessment report from BSI regarding a recommendation against continued certification in connection with prior audit nonconformance, was upheld. As a result, the Company will proceed through the routine BSI assessment process without suspension or interruption of the Company's sale of products in the EU.

"We are pleased by our successful appeal to BSI's assessment report. Our team's swift response and positive interaction with BSI, resulted in no interruption of sales of KORU Medical's products to the market and our patients," said Linda Tharby, KORU Medical's President and CEO. "Our products remain certified, marketed and sold in the EU, and we are excited by the continued expansion of our international business."

Posted In: KRMD