Training Features

Introduction to Global Complaint Handling and Vigilance

Learn how to evaluate, investigate, and report medical device and IVD complaints across major global jurisdictions while maintaining compliance with QMS expectations.  
Format

E-Learning

Level

Beginner

Trainer

Nicolas Garrett

Exam

Exam and certificate included

Duration

30 minutes
7 modules

Price

€ 95 or equivalent currency

The Essentials of Global Complaint Handling & Vigilance

In the medical device and in vitro diagnostic (IVD) industries, how your organization responds to product feedback isn't just a business process, it is a critical regulatory obligation that directly impacts patient safety, product quality, and global market compliance.  

This interactive, 30-minute introductory e-learning course provides a clear and practical foundation in global complaint handling and vigilance. Designed for beginner-level learners, the training breaks down complex regulatory expectations into actionable insights, guiding you through the end-to-end complaint lifecycle: from initial intake to investigation, regulatory reporting, and final closure.  
What You Will Learn
Who Should Attend?
What is Included?
Course Details
By enrolling in this course, you will explore key post-market requirements and discover how effective complaint management drives continuous product improvement:  
  • Define what constitutes a complaint and distinguish it from a non-complaint. 
  • Understand the key steps in the global complaint handling workflow. 
  • Recognize events that may require regulatory reporting. 
  • Identify information that should be captured when receiving a complaint; 
  • Recognize situations requiring prompt escalation; 
  • Recognize the importance of complete, timely and traceable complaint records 
  • Understand the major regional reporting requirements and timelines. 
  • Explain how complaint handling connects with CAPA, risk management, and post-market surveillance. 
What is included in this e-learning?
  • Access to the Qserve Learn Training Portal
  • A training certificate upon completion of the training.
Access to any mentioned guidances or ISO standards that are not publicly available is not included in this e-learning.
  • Duration: Approx. 30 minutes.
  • Format: Self-paced e-learning (video, interactive content, and quizzes).
This training is ideal for anyone new to the medical device or IVD sector, as well as professionals seeking a structured refresher on post-market regulatory responsibilities:  
  • Quality Assurance & Regulatory Affairs Associates: Early-career QA/RA professionals needing a clear overview of global complaint files, vigilance reporting clocks, and QMS integration.  
  • Customer Support & Intake Specialists: Frontline customer service representatives responsible for receiving incoming feedback, identifying potential complaints, and logging accurate initial records.  
  • Sales, Commercial, & Field Representatives: Client-facing personnel who regularly interact with healthcare professionals, distributors, and facility staff and must recognize when user feedback requires formal escalation.  
  • Technical Support & Field Service Engineers: Technical teams evaluating returned products, servicing equipment, or troubleshooting issues who need to understand how failure modes feed into complaint handling.  
  • Cross-Functional MedTech Professionals: Anyone across R&D, manufacturing, supply chain, or operations looking to understand how post-market feedback protects patients and maintains regulatory compliance worldwide.  

Comprehensive Regulatory Expertise

Gain recognized certification, advance your regulatory career, and learn at your own pace with a flexible learning schedule designed for medical device professionals.
Upon successful completion of the program, participants receive a recognized certification, boosting their career prospects and demonstrating their expertise to employers and clients.

Certification and Career Advancement

We offer a flexible learning schedule, allowing professionals to balance their training with their busy work and personal lives, ensuring accessibility to a wide range of learners.

Flexible Learning Schedule

Modules

Explore the training modules available in this course

Meet the Trainer

Nicolas Garrett

Nicolas Garrett, MSc, is an IVD regulatory and technical expert with over seven years of experience across US and European manufacturers, specializing in FDA 510(k) submissions, EU IVDR technical documentation, performance evaluation, risk management, analytical and stability testing, post-market activities, and international IVD standards.