Quality

The company was certified to DIN EN ISO 9001 from 1996-2003. From 2003, certification in accordance with DIN EN ISO 13485 took place. Biovision was one of the first companies in Germany to receive risk class III approvals for medical devices.
We are currently seeking MDR approval for our products and, in agreement with our Notified Body, we are making use of the possibility of extending the transitional periods. A PDF of the official confirmation and a PDF with our manufacturer's declaration can be found at the bottom of this page.