Dirigeants et représentants réglementaires de 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
Masqué
HAUFF Daniela
Article 15.3 (a) - Deputy
- responsible for the conformity of the quality management system with regulatory requirements
Masqué
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)
Masqué
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)
Masqué
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)
Masqué
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)
Masqué
DITTMAR Laura
Article 15.3 (a)
- responsible for ensuring that the conformity of the devices is appropriately checked before they are released at the Hanau site
Masqué
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
Masqué
LUNDGREN Lars
Article 15.3 (a)
- responsible for ensuring that the conformity of the devices is appropriately checked before they are released at the Mölndal site