Access Bio, Inc.

PRRC for Regulatory Affairs: Ensuring technical documentation and EU Declaration of Conformity are maintained and updated as per IVDR requirements. Serving as primary liaison with Notified Bodies and Competent Authorities regarding regulatory compliance matters.

PRRC for Quality Management System: Ensuring compliance of devices with the quality management system requirements under EU IVDR. Ensuring proper documentation and procedures in alignment with regulatory standards. Reporting directly to the top management on matters concerning QMS. Overseeing vigilance activities, post-market surveillance, and reporting obligations under EU IVDR.