Complaint Management for Medical Device Manufacturers

It is very important for manufacturers to properly respond to reports of alleged medical device problems. This course covers the FDA regulations for reporting these problems. Topics include: Definition, System Elements, Complaint File, Investigation, MDR, and Complaint Analysis. After completing this 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.

After this course learners will be able to identify the primary elements in an effective complaint handling system. recognize how to document complaint information as required by fda regulations and identify the basic requirements for complaint evaluation and investigation. recognize the types of complaints that must be reported to fda according to the medical device reporting (mdr) regulations and identify the importance of using statistical techniques in analyzing complaint trends that may indicate potential quality problems.