EndyMed Medical Ltd.

1.To draw up and keep up-to-date the Technical Documentation and the EU declaration of conformity; 2. To ensure that the PMS obligations are complied with in accordance with the requirement of the MDR; 3. To ensure that Reporting obligations are fulfilled in accordance with the requirement of the MDR.

1.To ensure conformity of the devices is appropriately checked, in accordance with the QMS under which the devices are manufactured, before a device is released; 2. To ensure that the PMS obligations are complied with in accordance with the requirement of the MDR; 3. In the case of a investigational devices, issuing a signed statement that the device in question conforms to the GSPR requirements apart from the aspects covered by the clinical investigation;.