Our Quality Management System is certified according to DIN EN ISO 13485. 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 System furthermore fulfills the requirements of:
US FDA (QSR/GMP 21 CFR 820), Kanada (CMDR/CMDCAS), Australien (TGR) und Japan (PAL).
Our Quality Management Certificates in PDF format