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Dublin, Ireland, 2012/09/04 - Argutus Medical Ltd, an EKF Diagnostics Company announces that its Quality Management System has received ISO 13485:2003 certification. The assessment was carried out by the notified body BSI (British Standards Institute) - ArgutusMed.com.
Argutus Medical Ltd, an EKF Diagnostics Company (AIM: EKF), is pleased to announce that it’s Quality Management System has been certified as fulfilling the requirements of ISO 13485:2003. The scope of this certification covers the Design, Development, manufacture and distribution of in-vitro diagnostic biomarkers to assess organ damage.
The assessment of Argutus Medical’s Quality Management System was performed by British Standards Institute (BSI), a world leader among notified bodies.
Joe Keenan, General Manager at Argutus Medical welcomed this significant landmark and said that the completion of the audits is evidence of the company’s persistence in maintaining only the highest quality products. "At Argutus, we are constantly striving to uphold the highest quality standards for our company and our products," he said. "Earning these certifications shows that our pursuit of quality is paying off and it will benefit our customers greatly."
As a globally recognised quality management system certification for medical devices and related services, receipt of ISO 13485 certification confirms Argutus Medical’s ongoing commitment to meet the requirements of its customers and regulatory bodies.
About Argutus Medical Ltd, an EKF Diagnostics Company
Argutus Medical Ltd (argutusmed.com) is a world leader in the development, manufacture and supply of a variety of test kits for the early detection of injury to organs such as the kidney and liver. Argutus Medical is based in Dublin, Ireland and since 2010 has been part of EKF Diagnostics Holdings plc (AIM:EKF) a publicly listed Healthcare company that is headquartered in Cardiff, Wales, UK.
EKF Diagnostics Holdings plc specialises in the development, manufacture and distribution of point of care analysers for hemoglobin, HbA1c, glucose, lactate as well as a range of clinical chemistry products and biomarker-based ELISA & rapid tests. EKF Diagnostics has nine sites in six countries and employs 295 people as of 31 December 2011.