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VISUS Health IT GmbH
Gesundheitscampus-Süd 15
44801 Bochum, Germany
FON +49 234 93693-0
FAX +49 234 93693-199
info(at)visus.com
www.visus.com
Directions: Link to road description
VISUS IT Solutions AG
Fraumünsterstrasse 29
CH-8001 Zürich, Switzerland
FON +41 44 552 24 80
FAX +41 44 552 24 83
info(at)visus.com
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. The EU Medical Device Regulation (2017/745) will replace the Directive 93/42/EEC. We are now preparing to fully comply with the new regulation in accordance with the transitional provisions and time lines. We currently possess additional certifications and authorizations that enable placing our medical devices on the market in many countries. For example, the FDA has granted us to market JiveX in the USA.
File name | Type | Size |
---|---|---|
Certificate ISO 13485 | 298 KB | |
FDA Letter | 276 KB | |
Certificate ISO 9001 | 600 KB | |
EC-Certificate of Conformity | 193 KB |
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Our contact will be glad to help you further.
Vice President Processes and agile Services
Fon +49 234 93 69 30