PK Benelux BV

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.

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.