• Conformity of the product device 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)
• Compliance with the Vigilance Reporting obligations (Article 87 to 91)
• For Investigational devices: Issuance of a signed statement (Annex XV Chapter II Section 4.1)
Masqué
CHAUDHARY Upendra Narayan
• Conformity of the product device 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)
• Compliance with the Vigilance Reporting obligations (Article 87 to 91)
• For Investigational devices: Issuance of a signed statement (Annex XV Chapter II Section 4.1)