Recall & MDR management
Know which recalls affect your fleet — and prove you acted
CogniQuip ingests FDA recall and enforcement data and matches it to the devices you own, turning field actions into tracked remediation work orders with the evidence retained.
The challenge
Recall notices arrive by email and PDF, and matching them to your inventory by hand is slow and error-prone. CogniQuip does the matching and gives you a defensible remediation trail.
FDA 21 CFR 803FDA UDI / GUDID21 CFR PART 11
app.cogniquip.com/workorders
What you get
How CogniQuip handles recall & mdr
Automated recall matching
openFDA recall and enforcement data matched to your devices by identifiers.
Remediation as work orders
Spin up and track recall-remediation work orders against affected devices.
Fleet-wide exposure view
See every affected device, location, and status in one place.
MDR-ready records
Retain the documentation needed for adverse-event reporting (21 CFR 803).
Bring Recall & MDR under one platform
A walkthrough tailored to your device fleet — compliance, calibration, and all. No obligation.