Stay cleared.
Stay compliant.
Stay ahead of recalls.
Clearance isn’t the finish line — it’s the starting gun for post-market obligations. Complizen monitors MAUDE for signals on your device type, tracks your complaint pipeline, generates periodic safety reports, and flags recall trends before they reach your device.
Every post-market obligation, tracked in one place.
MDR / MAUDE monitoring
Automated monitoring of MAUDE for your device type. Weekly summaries, signal detection, and trending analysis — delivered to your dashboard.
Complaint handling
Log complaints, link to MDR obligations, track investigation status, and generate 30-day MDR reports — all within your Complizen workspace.
Periodic safety reports (PSUR)
Draft your annual or periodic safety update reports with pre-populated signal data, complaint summaries, and benefit-risk conclusions.
Trend analysis
Track complaint and MDR rates over time. Surface statistically significant trends before they become reportable events or recall triggers.
Recall intelligence
Monitor FDA recalls in your device category. Get notified of Class I events and competitor recalls that could affect your device's safety profile.
Risk file linkage
PMS events link back to your ISO 14971 risk file. A new MAUDE signal can update a hazard probability estimate — automatically, with audit trail.
The FDA doesn’t stop watching after clearance. Neither should you.
MDR reporting deadlines are 30 days from becoming aware of a death or serious injury, 5 days for certain events. Missing them is a 483 finding. Complizen keeps the clock for you.