MEDIAN Technologies, the leading provider of clinical applications for quantitative management of response to therapy in oncology imaging, today announced it recently had its Quality Management System certified to the requirements of EN ISO 13485:2003 + AC:2007 and of the Canadian Medical Device Conformity Assessment System (CAN/CSA ISO 13485:2003) by TÜV Nord, one of the world’s leading certification bodies. ISO 13485 is an internationally recognized standard developed to ensure that companies providing medical devices meet regulatory requirements.
TÜV Nord also certified the MEDIAN LMS products consisting of LMS-Lung, LMS-Liver and LMS-Colon in conformance with the European Medical Device Directive 93/42/EEC amended in 2007 which came fully into force since 21 March 2010, thereby authorizing CE marking of these products as CE Class IIa.
“We have dedicated significant resources to our Quality System and are very pleased with the progress we have made”, said Fredrik Brag, Chief Executive Officer of MEDIAN Technologies. “These certifications validate our team’s continuing commitment to deliver very high-quality medical devices and related services to our customers. They represent a significant milestone for us and will allow the company to strengthen its worldwide market presence”