Nurami medical

("PRRC") per EU MDR Article 15: Section a Section c Section d (partially): Ensures that complaint handling, investigations, risk evaluation, PMS data, and CAPA records are completed, controlled, and provided to Regulatory Affairs to support timely and accurate reporting. Section e: In the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.

("PRRC") per EU MDR Article 15: Section b: The technical documentation and the EU declaration of conformity are drawn up and kept up to date Section d (partially): Is responsible for determining reportability, preparing and submitting all vigilance reports (including MIRs, trend reports, and FSCAs/FSNs), maintaining EUDAMED vigilance interactions, and serving as the primary contact with Competent Authorities.