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

 
  October 18, 2012  
     
 
Center for Professional Innovation & Education, Inc., Los Angeles, CA
Mar 20 & 21, 2013


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.
 
 
Organized by: Center for Professional Innovation & Education, Inc.
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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