$247 — Standard Tier

Complaint Handling & MDR Reporting Toolkit: FDA 820.198 & Vigilance

Complete complaint handling toolkit with FDA 820.198 compliant procedures, MDR reportability assessment, and vigilance reporting templates.

7-day money-back guarantee • One-time purchase • Instant download

What's Included

Complaint Handling Procedure (SOP)

Complaint Intake Form

Investigation & Root Cause Template

MDR Reportability Decision Tree

FDA MDR Report Template (Form 3500A)

EU Vigilance Report Template

Complaint Trending Report Template

Never miss an MDR reporting deadline

Consistent complaint investigation process

Clear reportability decision criteria

Trending data to identify product issues

This toolkit is designed for teams facing these challenges:

Complaints not handled consistently

Unsure which complaints require MDR

Missed MDR reporting deadlines

No trending or analysis of complaints

QA managers responsible for complaint handlingRA professionals handling MDR reportsCustomer service teams receiving complaints

30 days for most events, 5 days for events requiring remedial action. Templates include timeline guidance.

No. Decision tree helps determine if event meets death, serious injury, or malfunction criteria.

$247

$247

$247

Download immediately after purchase. All templates are editable Word and Excel files.

7-day money-back guarantee