Failure Investigations for Medical Device Manufacturers

Handling medical device failures can be significant in a company’s ability to maintain a state of control in operations and prevent future failures. This course will explore what a failure is, the regulatory and practical aspects of investigations, and the elements that make these investigations effective. Topics in this course include: Product Failure, Investigations, Root Cause, CAPA, Follow-up, and Documentation. After completing this course, learners should be able to recognize the basic definition of failures, identify when a failure investigation should occur, and the documentation required. 

After this course learners will be able to recognize the basic definition of failures. identify when a failure investigation should occur and the documentation required. identify the basic elements of a comprehensive failure investigation and the steps for management review and follow-up.