Quality Management

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.