-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
-In the case of investigational devices, the required statement is issued
-Be registered and update the information in EUDAMED in due time, as required
Hidden
MATUSZCZYK Arleta
-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 post-market surveillance obligations are complied as required
-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
Hidden
MISLIN Ines
- The post-market surveillance obligations are complied
-The reporting obligations are fulfilled
- 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