Medical product law requires a certified quality control system from every medical product manufacturer, supplier, and service company. The DIN EN ISO 9001 is an international standard that sets out the general requirements for a comprehensive quality control system. The additional
standard for medical products is the European and German standard DIN EN 46001. A company like MEDIMEX certified under both DIN EN ISO 9001 and DIN EN 46001 therefore vouches that the medical products it supplies are produced and/or processed under defined controlled conditions.
