DIN EN ISO 13485:2003

The certification of a quality management system according to the above mentioned standard is important, especially for those enterprises which have to fulfil legal conditions but do not necessarily have the duty of certification in regard to the Medical Products Regulations.

This covers enterprises which develop, service and distribute medical devices as well as IVDs and want to assure their productivity and competitiveness in national and international markets (especially in Northern America and Asia). This applies also to their suppliers and other service providers.