•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)