-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 -Be registered and update the information in EUDAMED within a period of one month following a change to this information, confirm the validity of the information one year after submitting it and every second year thereafter
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IDLER GROSSMANN FELIX Thais
-The technical documentation and the EU declaration of conformity are drawn up and kept up-to-date -The post-market surveillance obligations are compiled as required -The reporting obligations are fulfilled as required -In the case of investigational devices, the required statement is issued -Be registered and update the information in EUDAMED in due time, as required