Officers and regulatory representatives of Dentsply Sirona
ERICSON Christina
Article 15.3 (a), (b), (c), (d), (e)
Primary PRRC
Article 15.3 (a)
- responsible for the conformity of the quality management system with regulatory requirements
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HAUFF Daniela
Article 15.3 (a) - Deputy
- responsible for the conformity of the quality management system with regulatory requirements
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BERGNER Norbert
Article 15.3 (c) and (d)
- responsible for compliance with Post-Market Surveillance obligations (in accordance with Article 10 (10)) and
- responsible for fulfillment of reporting obligations (Articles 87 to 91)
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OKUKA Ana-Maria
Article 15.3 (c) and (d) - Deputy
- responsible for compliance with Post-Market Surveillance obligations (in accordance with Article 10 (10)) and
- responsible for fulfillment of reporting obligations (Articles 87 to 91)
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HJORTMO Sofia
Article 15.3 (b) and (e)
- responsible for the approval and maintenance of the Declaration of Conformity
- responsible for ensuring that the Technical Documentation is maintained and up to date
- responsible for issuance of statement for investigational devices confirming that the device in question conforms to the general safety and performance requirements (Section 4.1 of Chapter II of Annex XV)
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KALAITSIDOU Chrysi
Article 15.3 (b) and (e) - Deputy
- responsible for the approval and maintenance of the Declaration of Conformity
- responsible for ensuring that the Technical Documentation is maintained and up to date
- responsible for issuance of statement for investigational devices confirming that the device in question conforms to the general safety and performance requirements (Section 4.1 of Chapter II of Annex XV)
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MELNYK Olena
Article 15.3 (a)
- responsible for ensuring that the conformity of the devices is appropriately checked before they are released at the Hasselt site