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United StatesComplaint Handling in Medical Devices Training
This course introduces the fundamentals of Complaint Handling for medical devices, based on FDA Quality System Regulation (21 CFR Part 820.198)
You will learn what constitutes a complaint, how to document and investigate it properly, and why robust complaint handling is essential for patient safety, regulatory compliance, and continuous product improvement.
Through examples and scenarios, this training equips employees with the knowledge to recognize, escalate, and manage complaints effectively.
Our eLearning is a highly interactive way to learn at a time & a pace that works best for you, making it easier to get the training you need while balancing a busy home or work life.
Overview of our Complaint Handling in Medical Devices
What's covered on our Complaint Handling in Medical Devices Training
An interactive, engaging eLearning experience that you can complete Anytime, Anywhere.
Michelle Keane
Eoin Philip Kelly
At the end of this short course, successful learners will be able to:
- Define what a complaint is under FDA regulations
- Explain why complaint handling is critical for compliance and patient safety
- Describe the FDA requirements in 21 CFR 820.198 for complaints files, evaluations, and investigations
- Recognize when complaints trigger Medical Device Reporting (MDR) or Corrections/Removals (Recalls)
- Apply best practice for documenting, escalating, and supporting complaint investigations
This course is for individuals or organizations who want to understand Complaint Handling in the Medical Device Industry (with FDA Focus)
Successful completion of the course examination will entitle each Learner to receive a digital Certificate of Completion.
In order to successfully complete this course, each Learner will need to:
- Complete all eLearning modules and obtain 70% or higher in the final assessment (MCQ-based)
There are recommended requirements for each Learner in wishing to complete any of our eLearning modules. In our experience, Workplace IT environments’ internal configurations and available software can vary (new or old), and there may be various limitations or other restrictions in place, and as such, the functionality of any Learning Management System (LMS) may be impacted, restricted and may not perform well. Read the full technology requirements here.
Have 5 or more that need training?
We offer group discounts and are available for in-house (live or virtual) or tailored training in multiple formats.
Frequently Asked Questions
No, this micro-credential is only available for groups of 10 or more, or for licensing (annual subscription) on your organization’s Learning Management System (LMS). For more information, visit our licensing page or complete our contact us form and a member of our team will be in touch.
Once you have successfully completed the training, including all assessments, your certificate will be available within 1 business day. To access your certificate, you must first submit a short course survey and then the certificate will be available for download/print from your learner dashboard.
Please note: no certificates are available without full payment on file.
The eLearning duration provided is based on the average amount of time it takes an average learner who is new to the subject/topic.
In reality, the amount of time it takes to complete the eLearning will vary depending on your prior experience, knowledge & learning style.
To complete this course successfully, you will need to fully complete each module and obtain 70% or higher in the applicable assessment(s).
All graded assessments are MCQ-based.
Not all eLearning is the same
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