Officers and regulatory representatives of NEOLIFE WIZARD
LOPES FONSECA Filipe
Among additional duties, the main responsibilities are the ones 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)