NEOLIFE WIZARD, UNIPESSOAL, LDA

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)