Instructor
Edwin Waldbusser
This course will explain how to manage a design program that will meet FDA requirements and minimize chances of your medical device being recalled. ISO 13485 has almost identical requirements. Such a program will also help to get projects completed on time and within budget.
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 and a contents checklist discussed. The interrelationship between ongoing risk analysis and the design process will be explained. The new Human Factors requirements will be discussed.
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. These recalled products were tested before release and later failed in unanticipated ways that were not considered in the design and testing process. FDA also concluded that a well controlled design process with risk analysis, change control, design reviews, hardware/ software validation and feedback of the risk analysis results into the design process will greatly reduce chances of an unsafe product.
Handouts are pre release change control form, post release change control form, user requirements template, DHF checklist
