1.Conformity Check: Verifies device manufacture per QMS and Technical Documentation, and compliance with Annex II & III. 2. TD & DoC: Ensures TD is up to date and EU DoC remains accurate. 3.PMS Management: Ensures PMS plans/reports (Annex III Part B) are established and maintained. 4.Vigilance: Manages reporting of Serious Incidents and FSCAs per MDR Chapter VII Section 2. 5.Clinical Evaluation Review: Verifies clinical evaluation results (Annex XIV Part A) are documented and included in TD.