Dirigeants et représentants réglementaires de AI4MedImaging
SILVA Luisa
• Conformity of the devices are verified prior to production release, in accordance to the Medical Device Regulation and Quality Management System
• Conformity of the Technical Documentation and EU Declaration of conformity
• Compliance with Post-Market Surveillance (PMS) following Article 10(10)
• Vigilance reporting requirements are met for:
o Serious incidents
o Field Safety Corrective Actions (FSCA)
o Trend Reporting
o Analysis of serious incidents
o Analysis of vigilance data