1. Conformity of the product to MDR and QMS.
2. Conformity of the Technical Documentation and EU Declaration of Conformity.
3. Compliance with PMS following Article 10 (10).
4. Compliance with the Vigilance Reporting obligations (Article 87 to 91).
5. For Investigational devices: Issuance of a signed statement (Annex XV Chapter II Section 4.1)