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4-Hour Virtual Seminar: Risk Based Design Control Requirements

October 5 @ 8:00 am - 12:00 pm CDT



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.

Why you should attend

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 human factors analysis 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.


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Ijona Skills,364 E Main Street, Suite 1009
Middletown,DE,USA, DE 19709 United States
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+1 3028303132