Dirigeants et représentants réglementaires de Narcmed Kft.
KARANJAC Miloš
Among additional duties, the main responsibilities are the one mentioned on Article 15 of the EU MDR 2017/745:
Conformity of the product device to the Medical Device Regulation and Quality Management System
Conformity of the Technical Documentation and EU Declaration of conformity
Compliance with Post-Market Surveillance (PMS) following Article 10
Compliance with the Vigilance Reporting obligations
For Investigational devices: Issuance of a signed statement