PRODUCTION and SAFETY
Certified medical products

The certification of our quality management system is one of the statutory prerequisites for the production of a medical product.

We maintain the current requirements of DIN EN ISO 13485:2012 and are certified according to RL 93/42/EEC as well as RL 90/385/EEC.

Our certificates as PDF download:

 

Certificate CMDR - ISO 13485_2003

 

Certificate - Din EN ISO 13485

 
 

Certificate of Conformity - CD 93_42_EEC Annex II

 
 

Certificate of Conformity - CD 93_42_EEC Annex V

 
 

Certificate of Conformity - Refill kits CD 90_38_EWG Annex 2