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, human factors 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.
Join expert speaker Edwin Waldbusser, in this engaging 60 min session which discusses the important and confusing question of when design control begins during the development process. This session will also discuss the difference between prerelease and post release change control as well as the Design History File (DHF), will be explained with a discussion on contents checklist. Lastly, this session will explain the interrelationship between ongoing risk analysis and the design process.
Who should attend?
At the Q&A session following the live event, ask a question and get advice unique to your situation, directly from our expert speaker.
Edwin Waldbusser is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting in the areas of design control, risk analysis and software validation for the past 8 years. Mr. Waldbusser has a BS in Mechanical Engineering and an MBA. He is a Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson...
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