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Quality Management

Our Quality Management System is certified according to DIN EN ISO 13485 and MDSAP (requirements of the regulatory authorities Australia TGA, Brasilia ANVISA, Health Canada, USA FDA, Japan MHLW/PMDA).

 

The focal point of our Quality Management System is the high quality requirement regarding the performance and safety of our products and the satisfaction of our customers

 

Medical devices produced by VBM fulfill the requirements of the Medical Device Directive (MDD) 93/42/EWG for Medical Devices and are identified with the CE Marking accordingly. Our products are manufactured and packed in Cleanrooms of ISO Class 8.

 


Our Quality Management Certificates in PDF format