KAZ Europe Sàrl

Deputy PRRC The main responsibilities as mentioned in Art. 15 of the EU MDR 2017/745: - Conformity of the product devices to the MDR and QMS before a device is released - Compliance with PMS obligations following Art. 10(10) - Compliance with the Vigilance Reporting obligations (Art. 87 to 91)

The main responsibilities as mentioned in Art. 15 of the EU MDR 2017/745: - Conformity of the product devices to the MDR and QMS before a device is released - Conformity of the Technical Documentation and EU Declaration of conformity - Compliance with PMS obligations following Art. 10(10) - Compliance with the Vigilance Reporting obligations (Art. 87 to 91) - For Investigational devices: Issuance of a signed statement (Annex XV Chap. II Section 4.1)

Deputy PRRC The main responsibilities as mentioned in Art. 15 of the EU MDR 2017/745: - Conformity of the product devices to the MDR and QMS before a device is released - Conformity of the Technical Documentation and EU Declaration of conformity - Compliance with PMS obligations following Art. 10(10) - Compliance with the Vigilance Reporting obligations (Art. 87 to 91) - For Investigational devices: Issuance of a signed statement (Annex XV Chap. II Section 4.1)