FDAnews Announces Process Validation for Devicemakers: Concepts, Methods and Models Management Report Share Article Does one’s device’s process validation program stand up to FDA scrutiny? Ensure compliance with these strategies and methods. Order today. WCG FDAnews Process Validation for Devicemakers: Does one’s process validation program stand up to FDA scrutiny? Process Validation for Devicemakers: Concepts, Methods and Models is a must to ensure medical devices are compliant. This management report walks one through each step of the validation process. It provides the information needed to make decisions along the way. And it presents validation strategies, methods and tools to use to ensure compliance. This report outlines inspection priorities and it explains the unique challenges of software validation step-by-step.