Quality and service are crucially important at VISUS. For this reason, we have implemented a comprehensive and consistent QM system. We make customer orientation a reality in all areas of the company. However, if you have any reason to complain, please do not hesitate to let us know.
For more than 10 years, VISUS has allowed its own QM system to be monitored and certified by external authorities. As a result, we focus both on meeting customer requirements (ISO 9001) and on the safety of our medical devices (ISO 13485). Our compliance with European requirements is confirmed by the authorization of our quality management system under Annex II of European Council Directive 93/42/EEC. We currently possess additional certifications and authorizations that enable placing our medical devices on the market in many different countries. Among other, JiveX is licensed in the USA by the FDA.
|Certificate ISO 13485||178 KB|
|EC-Certificate of Conformity||188 KB|
|Certificate ISO 9001||132 KB|
|Compliance declaration E DIN EN 80001||138 KB|
|Certificate Medical Device Licence Canada||163 KB|
|Certificate FDA Letter||195 KB|