$247 — Standard Tier

Complaint Investigation Toolkit: FDA 21 CFR 820.198 + MDR Reportability Templates

Complaint Investigation Toolkit — complaint procedure, investigation form, MDR reportability worksheet, root cause analysis template, trend dashboard, and CAPA escalation criteria.

Get the Toolkit — $247

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What's Included

Complaint Investigation Procedure (21 CFR 820.198 + ISO 13485)
Complaint Investigation Form and Tracking Log
MDR Reportability Decision Worksheet (21 CFR Part 803)
Complaint Root Cause Analysis Template
Complaint Trend Analysis and KPI Dashboard
Complaint-to-CAPA Escalation Criteria Template

Benefits

MDR reportability worksheet creates documented decision chain for every complaint including no-report determinations
Escalation criteria template defines objective CAPA thresholds eliminating inconsistent records
Trend dashboard pre-structured for ISO 13485 management review inputs
Investigation procedure covers FDA triage criteria distinguishing complaints requiring investigation

Is This For You?

This toolkit is designed for teams facing these challenges:

FDA 483 citing missing or inadequate MDR reportability documentation in complaint files
No documented criteria for when complaints escalate to CAPA
Complaint trend data not connected to management review
Investigation records inconsistent across complaint types

Who This Is For

QA managers responsible for complaint handling systemsRegulatory affairs leads managing MDR reporting obligationsOperations directors overseeing post-market surveillanceCompanies preparing complaint systems for FDA inspection

Frequently Asked Questions

What is the difference between a complaint and a non-complaint?

Under 21 CFR 820.198, a complaint is any written, electronic, or oral communication alleging deficiencies related to identity, quality, durability, reliability, safety, effectiveness, or performance of a device. The procedure template includes triage criteria for determining investigation scope.

How long do I have to submit an MDR report?

30 calendar days for deaths and serious injuries, 5 work days for events requiring remedial action to prevent unreasonable risk of substantial harm. The MDR reportability worksheet guides you through both timelines.

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Ready to Get Started?

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

Get the Toolkit — $247

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