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 ten years VISUS has had its own quality management system monitored and certified by external bodies. On the one hand, the focus is on the fulfillment of customer requirements (ISO 9001), on the other hand, the focus is on the safety of our medical products (ISO 13485). The fulfillment of European requirements is confirmed by the approval of our quality management system according to Annex II of Directive 93/42/EEC and according to Annex IX Chapter I of Regulation (EU) 2017/745. Currently, we have additional certificates and approvals that allow us to market our medical devices in many different countries. Among others, JiveX is approved by the FDA in the USA.
|Certificate ISO 13485||1 MB|
|FDA Letter||273 KB|
|Certificate ISO 9001||600 KB|
|EC-Certificate of Conformity||193 KB|
|EU Quality Management System Certificate||2 MB|