QA Manager / Management Representative performing PRRC responsibilities in accordance with Article 15 of Regulation (EU) 2017/745. Responsible for device conformity prior to release, Technical Documentation, EU Declarations of Conformity, Post-Market Surveillance (PMS), PMCF, PSUR, Vigilance activities and reporting obligations under Articles 87-91 MDR. Responsibilities are shared with the RA Manager / PRRC in accordance with the Company's Quality Management System.
Masqué
MOYAKINE Vadim
RA Manager / PRRC ensures compliance in accordance with Article 15 of Regulation (EU) 2017/745 and the Company’s QMS, including device conformity prior to release, Technical Documentation, EU Declarations of Conformity, Post-Market Surveillance (PMS), PMCF, PSUR, Vigilance activities and reporting obligations under Articles 87–91 MDR, ensuring ongoing regulatory compliance throughout the product lifecycle.
Masqué
Cartographie de PK Benelux BV
FabricantImportateurMandataireFabricant de systèmes ou nécessairesPersonnes