ISO 13485 certification for MEDIAN, CE mark class IIa for the LMS portfolio
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”
About Median Technologies.
Median Technologies develops medical imaging software and services dedicated to oncology clinical trials, cancer screening, and clinical practice. Median Technologies standardizes and automates the interpretation of medical images in oncology to optimize the diagnosis of cancer patients and the assessment of their response to therapy. Median serves two primary markets: drug development and patient care. Median has a strategic partnership with the world’s largest CRO (Contract Research Organization) to offer integrated imaging services for clinical trials to biopharma sponsors worldwide, and a strategic partnership with Canon to develop new imaging technologies, and to address the patient care market.
Founded in 2002, Median Technologies is based in Sophia-Antipolis, France, and has a US subsidiary in Boston. Median has a global reach and actively works with clinical sites located in Asia, Europe, North and South America, and Australia.
Median has received the label “Innovative company” by the BPI and is listed on Euronext Paris’ Alternext market (ISIN: FR0011049824, ticker: ALMDT). The company is eligible for the PEA PME SME equity savings plan setup.
“We are committed to the improvement of cancer patient outcomes through innovation in medical imaging and quality execution for better screening, diagnosis, and monitoring of patients.”