Complaints logged in email.
Reportable events missed.
Every complaint captured, investigated, and reported within regulatory timelines.
Every complaint captured, investigated, and reported within regulatory timelines.
The problem
Complaints arrive by email, phone, and sales reps - no single intake point
Reportable events not identified in time for MDR or MedWatch filing deadlines
Investigations lack structure - root cause not identified, risk not assessed
No systematic way to identify complaint trends that signal emerging quality issues
The solution
All complaints captured in one system with automatic classification and acknowledgment
Guided evaluation to determine if complaint requires regulatory reporting (MDR/MedWatch)
Investigation workflow with root cause analysis, risk assessment, and CAPA linkage
Automatic trend analysis across complaint types, products, and failure modes
Connects to your CAPA module - complaints that require corrective action flow directly into the CAPA process
Log complaints from any source with product, lot, and failure mode classification
Guided assessment determines regulatory reporting requirements and deadlines
Structured investigation with root cause analysis and risk evaluation
Resolution documentation, CAPA linkage if needed, and ongoing trend monitoring
Missed reporting deadlines
Complaints with reportability assessment
Average investigation time
Trend detection
Needs complaint handling processes that meet ISO 13485 clause 8.2.2 and 21 CFR 820.198
Needs to assess reportability and file MDR/MedWatch reports within deadlines
Needs a simple way to log complaints and track resolution for customers
Structured complaint management with reportability assessment and trend monitoring - configured in 21 days.