Flexicare Medical Limited

Ensuring that 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. Ensuring the Post-Market Surveillance obligations are complied with in accordance with MDR Article 10(10). Ensuring that in the case of investigational devices, the statement referred to in Section 4.1 of Chapter 2 of Annex 15 (MDR) is issued.

Ensuring the Technical Documentation and the EU declaration of Conformity are drawn up and kept up to date. Ensuring the reporting obligations referred to in Articles 87 to 91 of the MDR are fulfilled.