Bien-Air Surgery SA

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

• 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)

• 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