Dirigeants et représentants réglementaires de Bien-Air Surgery SA
CORMIER Clémentine
the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released
Masqué
TSOLEKAS Dimitrios
• Conformity of the Technical Documentation and EU Declaration of conformity
• Compliance with Post-Market Surveillance (PMS) following Article 10(10)
• Compliance with the Vigilance Reporting obligations (Article 87 to 91)
Art. 87- Reporting of serious incidents and field safety corrective actions
Art. 90- Analysis of vigilance data
Art. 91- Implementing acts
• For Investigational devices: Issuance of a signed statement (Annex XV Chapter II Section 4.1)
Masqué
RAZAFINTSEHENO Rivo
• Compliance with the Vigilance Reporting obligations (Article 87 to 91)
Art. 87- Reporting of serious incidents and field safety corrective actions
Art. 88- Trend reporting
Art. 89- Analysis of serious incidents and field safety corrective actions
Art. 90- Analysis of vigilance data
Art. 91- Implementing acts