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Medical Devices

Complaint Management for Medical Device Manufacturers

About the Course

It is very important for manufacturers to properly respond to reports of alleged medical device problems. This eLearning course covers the FDA regulations for reporting these problems. Topics covered in this online course include: Definition, System Elements, Complaint File, Investigation, MDR, and Complaint Analysis. After completing this training course, you will be able to identify the primary elements in an effective complaint handling system; recognize how to document, evaluate, and investigate complaints; recognize complaints that must be reported under FDA regulations; and identify the importance of statistical techniques in analyzing complaint trends.