Risk Based Design Control
Duration : 60 Minutes
Edwin Waldbusser, Medical Device
Ed retired from industry after 30 years in management of development of medical device products and development of company Quality Systems. He was involved in the development of products such as IVD devices, kidney dialysis systems and inhalation devices. His QS experience includes, design control, risk analysis, CAPA, softwa Read more
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.
Course Objectives:
This training program will explain how to manage a design program that will meet FDA requirements and minimize chances of your medical device being recalled. The program will also help in getting projects completed on time and within budget.
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.
Course Outline:
• 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
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• Engineering personnel
• Software developers
• Development Engineers
• Production Management
• QA/ QC personnel
• Management
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
Contact Us
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