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Introduction to Medical Device Submissions - 510ks, PMAs, and Exemptions

  December 19, 2013  
Center for Professional Innovation & Education, Inc., Los Angeles, CA
Feb. 26 & 27, 2014

This course covers current FDA regulatory compliance with respect to developing and marketing medical devices. A focus will be placed on relevant aspects of FDA regulations and the practical aspects of bringing a medical product to market.

The course will initially cover the general context for medical device regulations. Later, a more in-depth discussion will begin to look at each of the submission categories in detail. FDA’s regulations, guidance documents, and on-line informational resources will be highlighted and used throughout the course.

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=127&source=hummolgen
E-mail: info@cfpie.com
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