Post-Market Vigilance

Marketed in vitro diagnostics can be indirectly responsible for unexpected or unwanted incidents affecting patient safety. When you need to feel confident and secure in your device review process, our safety data specialists are ready to assist, with highly standardized systems and artificial intelligence capabilities. Our thorough identification of root-cause challenges will ensure that incidents are reviewed and reported properly to keep your product in compliance.

Postmarket vigilance solutions offered:

• Safety surveillance
• Case intake/call center
• Case processing
• Medical review
• Aggregate reporting
• Label changes