Screenshot of abstract orange background.

Medical Devices

Computerized Systems Inspections in the Medical Device Industry

About the Course

This online training course assists FDA inspectors in recognizing the critical aspects of computerized systems in the medical device industry. This course explains how computerized systems are used in the medical device manufacturing process and provides an approach to inspecting these systems. This eLearning course does not cover the detailed review of software that forms part of a medical device; it covers only inspection of systems that automate part of the device production process or quality system. Before taking this online course, users should complete Requirements for Computerized Systems Validation and Compliance and Approach to Computerized Systems Validation and Compliance.