AVAPEZESHK

Responsible for ensuring that each device is compliant with MDR 2017/745 before being placed on the market; overseeing the preparation and maintenance of the EU Declaration of Conformity and Technical Documentation; ensuring that post-market surveillance and vigilance obligations are fulfilled, including reporting of serious incidents and field safety corrective actions; and cooperating with Competent Authorities and Notified Bodies during audits or regulatory inspections.