Risk Based Design Control
Instructor:
Edwin Waldbusser
Product ID: 704548
- Duration: 60 Min
Why Should You 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 feedback of the risk analysis results into the design process will greatly reduce chances of an unsafe product.
The important and confusing question of when, in a development process, design control begins will be answered in this webinar. The difference between prerelease 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 also be detailed.
Areas Covered in the Webinar:
- Reasons for design control
- When design control begins
- Elements of a design control program
- How risk managements fits into design control
- Change control
- Understanding validation consists of more than testing
- Design History File
Who Will Benefit:
- Development Engineers
- Production Management
- QA/ QC Personnel
- Software Developers
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 Reuters Expert Witness network.
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