Quality System

All Mona Lisa IUDs fulfill the high quality requirements of internationally registered norms, such as the Council Directive 93/42/EEC Annex II.

Furthermore, Mona Lisa is certified according to the quality management standards ISO 13485:2016 and CAN/CSA ISO 13485:2003. Mona Lisa N.V. is audited by the reputable SGS Belgium NV.

The strict quality criteria also apply to all suppliers.

Mona Lisa IUDs are manufactured in a modern Class 10.000 (ISO 7) production complex and are continuously and thoroughly tested to ensure that they fulfill quality standards.