Officers and regulatory representatives of Eska Diagnostics Kft
ABED SALIMI Payam
Essential Duties and Responsibilities:
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(10)
- Compliance with the Vigilance Reporting obligations (Article 87 to 91)