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 13485:2003, CAN/CSA ISO 13485:2003 and EN ISO 13485:2012. Mona Lisa N.V. is audited by the reputable SGS Yarsley Int. Certification Services.

The strict quality criteria also apply to all suppliers.

Mona Lisa IUDs are manufactured in a modern Class 100.000 (ISO 8) production complex and are continuously and thoroughly tested to ensure that they fulfill quality standards.

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