Complaint Handling in Medical Devices Training

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.