Quality

ISO 13485 certification

MEDIAN Technologies has set up a quality assurance system regarding its overall activities of product development, distribution, support and services.

MEDIAN Technologies’ Quality Assurance System has been certified by the notified body, TÜV Nord, as being in conformity with EN ISO 13485:2003 + AC:2007 and CAN/CSA ISO 13485:2003CAN norms.

ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.

Marketing Authorisations

European market: TÜV Nord has also certified Lesion Management Solution (LMS) product family from MEDIAN Technologies in compliance with the European 93/42/CEE directive updated in 2007, authorizing the CE (European conformity) marking of its products to class 2a and thus allowing marketing in Europe.

US market: MEDIAN Technologies has received 510(k) FDA clearance to market LMS-Liver and LMS-Lung/Track on the US market.

Australian and New Zealand markets: MEDIAN LMS software suite has been registered in the Australian Registry of Therapeutic Products (GTPA), as well as in the New-Zealand registry of medical devices (NZ Wand database) and has been placed in Australian and New Zealand markets.