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Medical Device Complaint Handling, Event Reporting, and Recall Management Training

Regulatory investigations and third-party audits often begin by examining complaint data because its appropriate management is essential to an effective QMS. Given newly accelerated timelines for reporting events of harm or potential harm in the EU and other countries, as well as an increased focus by US FDA, efficient complaint identification, investigation, and decision making has never been more critical. During this training, participants develop skills to increase effectiveness and efficiency throughout the complaint-handling process and understand how their efforts contribute to regulatory compliance, product improvement, and customer satisfaction. 

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Brief Overview of This Complaint-Handling Process Class

SkillsLab Class ?

Class Content


Class Duration

5 Half-Days

Teaching Format

Live, Instructor-Led

Delivery Options

Virtual or In Person*

Certification of Completion


Continuing Education Units (CEUs)


* SkillsLab classes delivered in-person are full-day sessions delivered over 3 consecutive days.

** Interested in private training for your team, virtually or in-person at your facility? See more details or ask us about it!

Upcoming Classes

Upcoming Medical Device Complaint-Handling Training Classes

SkillsLab $3295

Course Code Location Class Begins Class Ends Daily Schedule Course Delivery Class Agenda Registration
CHF VIRTUAL DELIVERY (Eastern Time) 03 Jun 2024 07 Jun 2024 1:00PM - 5:00PM Eastern US Time Virtual REGISTER
CHF VIRTUAL DELIVERY (Eastern time - PM) 21 Oct 2024 25 Oct 2024 1:00PM - 5:00PM Eastern US Time Virtual REGISTER


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*This offer cannot be combined with any other promotional offer(s).

Course Overview

Here's What We Cover in This Intensive Complaint-Handling Course

Using a hands-on learning approach, you'll work through the complete medical device complaint-handling process: intake, triage, investigation, closure or escalation, recall management, and reporting, and at the end of the class, you'll have the skills needed to increase effectiveness and efficiency throughout the complaint-handling process.

Course Overview
SkillsLab Class

Complaint Basics and Regulatory Requirements

  • Sources of feedback
  • Key terminology for complaint handling
  • Feedback-related requirements (US FDA and ISO 13485:2016)
  • Complaint-handling requirements (US FDA and ISO 13485:2016)
  • Difference between feedback and complaints
  • Standard complaint-handling activities used globally
  • Role of postmarket surveillance and review-driven activities in complaint handling
  • Relationship between complaint handling and other processes
Exercise! Identify Complaints

Complaint-Handling Unit Strategies

  • Developing a complaint-handling process
  • Organizing the complaint-handling unit
  • Metrics to demonstrate complaint-handling system effectiveness
  • Best practices for complaint handling
  • Examples of US FDA observations

Complaint Intake and Triage

  • Data sources for complaints
  • The importance of the initial contact
  • Types of data to include in the complaint file
  • Potentially reportable event (pRE) decision criteria
  • Initial triage activities
Exercise! Intake and Triage

Complaint Investigation and Closure

  • Levels of complaint investigation and their activities
  • Common investigation tools
  • The link between complaint handling and corrective and preventive action (CAPA)
  • Role of root cause investigations
  • Risk-based approach for complaint handling
  • Complaint closure activities
  • Complaints as an input to management review
Exercise! Investigation and Next Steps

Risk Management

  • Basic principles of risk management
  • Role of risk in postproduction
  • Incident-driven risk assessment
  • Risk-based decision-making tools for corrections and CAPA

Medical Device Reporting in the US

  • Terms used to describe reportable events
  • The high-level event reporting process
  • Common event information to collect
  • Events that must be reported to US FDA
  • US FDA event reporting timelines
  • US FDA’s MAUDE database and electronic submission (eMDR) process
Exercise! US MDR Reportability Decisions

Vigilance Reporting in the EU

  • EU MDR requirements for vigilance reporting
  • MEDDEV guidance document for vigilance reporting
  • EU MDR recording of reported incidents
  • Trend reporting requirements in the EU MDR
Exercise! EU MDV Reportability

Incident Reporting in Canada and Event Reporting in Other Jurisdictions

  • Incident reporting decision criteria for Canada
  • Canada’s incident reporting time frames
  • Event reporting requirements in other MDSAP countries (Australia, Brazil, Japan)
Exercise! Canada Reportability Decisions

Risk-Based Approach to Corrections and Removals

  • External action terminology
  • Difference between removals and recalls
  • Types of issues that trigger a recall
  • Recall planning
  • Recall notification to Regulatory Authorities
Exercise! Risk Assessment and the HHE

Recall Management and Field Actions

  • Recall communications
  • Advisory notices and field safety actions
  • Managing consignee lists for recalls
  • Evaluating the effectiveness of a recall
  • Reconciling and closing a recall
  • Final recall reporting requirements for Australia, Brazil, Canada, Japan, US, and the EU
Exercise! Create a Communication
Exercise! Effectiveness Check

Postmarket Surveillance

  • Overview of postmarket surveillance activities, requirements, and guidance
  • FDA’s Total Product Life Cycle (TPLC) database

Preparing for Inspections and Audits

  • What to expect related to complaint-handling activities during:
    1. FDA inspections
    2. Notified Body audits
    3. Medical Device Single Audit Program (MDSAP) audits
  • Preparing for audits and inspections of the complaint-handling process
What You Will Learn

What You Will Learn

At the conclusion of this training class, you will be able to

Assess customer feedback scenarios using the FDA definition and ISO 13485:2016 criteria to correctly identify alleged deficiencies, complaints, and potentially reportable events, and write effective problem statements. 

Discuss complaint-handling unit strategies and best practices to better integrate the function within the organization, measure its effectiveness, and add value to management review. 

Analyze complaint investigations to accurately determine appropriate next steps (e.g., closure or escalation to Level III investigation to determine the root cause) and reportability actions.

Discuss postproduction risk evaluation team formation and impact assessment. Review the types of incidents to document in a risk management standard operating procedure (SOP).

Determine reporting obligations for events in the EU and the MDSAP countries Australia, Brazil, Canada, Japan, and the US. Follow the process steps required to practice submitting a report in the US, EU, and Canada.

Apply a risk-based approach to needed corrections and removals by practicing the risk assessment process leading to a recall decision.

Prepare for an audit of the complaint-handling system by understanding and interpreting the reporting requirements in the EU MDR and the MDSAP countries Australia, Brazil, Canada, Japan, and the US.

Who Should Attend

Who Should Attend

This course is designed for complaint processors, complaint-handling unit organizers, and those who work closely with them to meet the organization's CAPA objectives and apply regulatory requirements for complaint handling, event reporting, recall management, and postmarket surveillance.

  • Quality Engineers
  • Complaint-Handling Personnel
  • RA/QA Managers
  • Internal Auditors
  • Customer-Facing Personnel

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