Area of responsibility include:
• Ensure named individuals are fulfilling designated role in meeting Article 15(3) requirements
• Participate in Legal Manufacturer Management Review
Masqué
JOSE Harish
Includes:
• Verifies device conformity per the QMS prior to release in accordance with EU MDR Article 15(3)(a).
• Serves as Manufacturer, Local Actor Administrator, and Local User Administrator in EUDAMED.
• Ensures required regulatory updates are maintained within applicable EUDAMED Actor sections.
• Monitors FSCAs and ensures reporting compliance per EU MDR Article 15(3)(c) and (d).
• Maintains and implements FSCA processes.
Masqué
EICHLER-HUSTON Susan
Area of responsibility include:
• Ensure Technical Documentation and Declaration of Conformity current in accordance with established procedures as outlined in EU MDR Article 15(3)b
Masqué
GEARY David
Area of responsibility includes:
• Issues release of clinical trial material compliant with the general safety and performance requirements as outlined in EU MDR Article 15(3)e
• Ensures every precaution has been taken to protect the health and safety of the subject as outlined in EU MDR Article 15(3)e