Regulatory Affairs

Visbion is an ISO 9001:2008 and ISO13485:2003 certified company. These ISO standards combine to specify requirements for a quality management system that the company needs to comply with, in order to provide medical devices and related services that consistently meet customer and regulatory requirements. Visbion’s ISO certificates are provided below.

Visbion’s PACS software systems are certified for use in the EU according to the 93/42/EEC-Medical Device Directive. The certificate is provided below.

Visbion has achieved 510(k) clearance from the US FDA to market the Visbion PACS in the United States (K140797).  Clearance includes the Image Archive, Image Web (of which the Image World product is comprised), Image Viewer and Image Importer software components.

For any additional information on our standards and certification, please email us at info@visbion.com.

Declaration of Conformity Issue 11
Directive 93-42-EEC Annex II
ISO13485-2012 UKAS Accredited
ISO 9001-2008 UKAS Accredited