Products
Turn a Crisis Into a Controlled Process.
Manage recalls and Field Safety Corrective Actions (FSCA) with surgical precision. Track affected units, notify customers, and report to authorities.
Global Tracking
Map view of all affected devices. Drill down to see which hospital has the unit and what the status is.
Automated Communication
Send bulk notifications (Letter, Email) to consignees and track read receipts/acknowledgments.
Regulatory Reporting
Generate the reconciliation reports required by FDA, competent authorities, and notified bodies.
Execute FSCA Flawlessly
01
Define Scope
Input affected Lot/Serial numbers. System identifies all locations and customers.
02
Launch Action
Distribute the Field Safety Notice (FSN). Customers log in to acknowledge receipt.
03
Remediate & Close
Track return/fix status per unit. Close the action when effectiveness checks are complete.
Hub Features
TraceabilityUnit-level tracking
NotificationEmail, Cert Mail Tracking
PortalCustomer/Distributor Reply Portal
SecurityHIPAA Compliant
ExportReconciliation Report (PDF/Excel)
MobileField Service App
FAQ
Q. How do customers reply?
A. They receive a secure link to a portal where they can confirm receipt and unit status.
Q. Can I use this for voluntary corrections?
A. Yes, it handles both voluntary corrections and mandatory recalls.
Q. Is it validated?
A. Yes, fully validated software for quality system use.