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

  January 14, 2014  
Center for Professional Innovation & Education, Inc., Berlin, Germany
Apr. 7 & 8, 2014

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.

This course has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for 12 credits towards a participant's RAC recertification upon full completion.

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&utm_source=Hum-Molgen&utm_medium=Course%20Listing&utm_campaign=Web%20Listing%3A%20Hum-Molgen
E-mail: info@cfpie.com
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