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Event

Design Validation, Verification, and Risk Analysis for Medical Device Professional

March 14, 2012, March 15, 2012 iCal


Location: Los Angeles, CA

Course Description:

This course covers current FDA regulatory compliance with respect to developing medical devices. Focus will be placed on relevant aspects of FDA regulation to V&V and Risk Analysis and the FDA's supplemental guidelines. An ISO perspective is offered to compliment the FDA view.

Among the topics to be discussed are: Context of V&V and Risk Analysis within the overall quality system and regulation, V&V and Risk analysis procedures, V&V methodologies, V&V strategies, types of risk analysis, risk mitigation, and methods to determine probability and severity for Risk analysis.

For more information please visit: http://www.cfpie.com/showitem.aspx?productid=118&source=lsam

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