Dirigeants et représentants réglementaires de Epsidy SAS
COTTANCE Myline
• Check for the conformance of the device to the established quality management system
• Keep all of the technical documentation up to date
• Keep all of EU declaration of conformity up to date
• Ensure post-market surveillance activities comply with Article 10(10) of the regulation
• Performing reporting procedures
• In the case of investigational devices, ensure that the statement referred to in Section 4.1 of Chapter II of Annex XV (MDR) is issued.