WomanCare Global, LLC

The post-market surveillance obligations are complied with in accordance with Article 10(10) of the MDR.

•The conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released. • The technical documentation and the EU declaration of conformity are drawn up and kept up-to-date. • The reporting obligations referred to in Article 87 to 91 of the MDR are fulfilled. • In the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV of the MDR is issued.