Computerized Systems Inspections in the Medical Device Industry

This course has been designed to assist 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 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 part of the quality system. Before taking this course, users should complete Requirements for Computerized Systems Validation and Compliance and Approach to Computerized Systems Validation and Compliance.

After this course learners will be able to recognize where computerized systems are used in the medical device manufacturing process. recognize fda’s approach to inspecting computerized systems. identify the levels of review that may be used and what comprises each level.