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Medical Devices

Failure Investigations for Medical Device Manufacturers

About the Course

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 online learning 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 eLearning course include: Product Failure, Investigations, Root Cause, CAPA, Follow-up, and Documentation. After completing this training course, you should be able to recognize the basic definition of failures, identify when a failure investigation should occur, and the documentation required.