Officers and regulatory representatives of Spectre Technology d.o.o.
UGIDOS Saray
- 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), For Investigational devices: Issuance of a signed statement (Annex XV Chapter II Section 4.1)