Risk Based Design Control Requirements

This course will explain how to manage a design program that will meet FDA requirements and minimize chances of your medical device being recalled. The important and confusing question of when, in a development process, Design Control begins will be answered. The differences between pre release and post release change control will be explained. The Design History File will be explained. The interrelationship between ongoing risk analysis and the design process will be explained. The new Human Factors requirements will be discussed . Software validation, which is more than testing, will be explained.

Designing a medical device and testing it to prove it works is not sufficient in the eyes of the FDA to provide a safe product for users. The FDA has determined, through analysis of product recall data, that the majority of recalls were due to a faulty design process, not faulty manufacturing.