Medical Device Vigilance
Ensure safety and compliance for medical devices and combination products across global markets.
Medical Device Vigilance
Our Expertise
• Incident case management & trend analysis
• Serious Incident / Field Safety Corrective Action reporting
• PMCF / PMS Plans & Reports (EU MDR)
• Vigilance reporting to global authorities including EUDAMED
• Medical Device Safety Officer (MDSO) support
• Complaint handling oversight & CAPA alignment
• Risk–benefit evaluation & CER linkage