Bioxis Pharmaceuticals SAS

Responsible of product release under the manufacturer's Quality Management System Ensure compliance of technical documentation and declaration of conformity with regulatory requirements Ensure Post market surveillance / vigilance processes are followed in accordance with regulatory requirements Ensure GSPR statment apart from the aspects covered by the clinical investigation has been established and signed for investigationnal devices (Section 4.1 of Annex XIV)

PRRC substitute, ensuring the tasks mentioned in MDR Article 15