Regulatory Affairs
Visbion is an ISO 9001:2000 and ISO13485:2003 registered 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.
For any additional information on our standards and certification, please email us at This e-mail address is being protected from spambots. You need JavaScript enabled to view it .
| File | Description | File size |
|---|---|---|
 9342EEC Certificate | 9342EEC Certificate | 1105 Kb |
 ISO 13485:2003 Certificate | ISO 13485:2003 Certificate | 1109 Kb |
 ISO 9001 Certificate | ISO 9001 Certificate | 1129 Kb |
 EC Declaration of Conformity | EC Declaration of Conformity | 27 Kb |
