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Design Validation, Verification and Risk Analysis for Medical Device Professionals

  August 30, 2011  
Center for Professional Innovation & Education (CfPIE), King of Prussia, PA
Oct. 26 & 27, 2011

This course covers current FDA regulatory compliance with respect to developing medical devices. Focus will be placed on relevant aspects of FDA regulation to Validation & Verification (V&V), 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.
Organized by: Center for Professional Innovation & Education
Invited Speakers: Contact info@cfpie.com for a list of course instructors
Deadline for Abstracts: n/a
Registration: http://www.cfpie.com/showitem.aspx?productid=118&source=hummolgen
E-mail: info@cfpie.com
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