Two certificates of approval certify that the quality management system of Astra Tech follows the quality system standards ISO 9001:2000 and ISO 13485:1996. 
The ISO 9001:2000 standard is a general standard covering many branches. For medical devices, specific demands when applying the ISO 9001 is described in ISO 13485 (previously EN 46001).

Two certificates of conformity show that the medical devices manufactured under our quality management system will comply with the requirements of the Medical Device Directive (MDD) 93/42/EEC.The reason for having two different conformity certificates is that the MDD requirements vary depending on product class.

You can download the documents by clicking the links below.