Quality Management
Table of Contents
DIN EN ISO 13485:2003 and MDD 93/42/EEC Annex II.3
The Clinical Applications working group of the Division of Medical and Biological Informatics has introduced and applies a certified quality management system based on the DIN EN ISO 13485:2003 standard and MDD 93/42/EEC Annex II.3.
The products developed here conform to the German Medizinproduktegesetz (Medical Device Directive MDD 93/42/EEC) and bear the CE marking.
Quality Management Representative
last update: 31/08/2009
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