Certifications

WISE has obtained for its production site in Cologno Monzese the certification according to the standard ISO 13485:2016 (Medical devices - Quality management systems - Requirements for regulatory purposes).

The ISO 13485:2016 standard specifies the requirements for a Quality management system where an organization needs to demonstrate its ability to provide medical devices that consistently meet customer requirements and regulatory requirements applicable to medical devices.

The certification was granted by Tüv Süd on 27th October 2017, following a two-stage audit process. Tüv Süd carries out a continuous strict control in order to ensure that the quality standards of WISE’s production system are maintained over time.