Introduction to Medical Device Submissions – 510(k)s, PMAs, and Exemptions
October 1 - 2, 2014 - Malvern PA USCenter for Professional Innovation and Education, Inc.
info@cfpie.com
Phone:(610) 688-1708
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.