Certified by DQS and IQNet according to DIN EN ISO 13485 : 2003 (November 2003 edition)
Certified by DQS according to Annex II of Directive 93/42/EEC with respect to the following medical devices: Bioresorbable medical devices according to the annex
Download pdf ISO 13485 : 2003
Download pdf IQNet Certificate
Download pdf Annex II of Directive 93/42/EEC