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Introduction to Medical Device Submissions – 510(k)s, PMAs, and Exemptions
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Introduction to Medical Device Submissions – 510(k)s, PMAs, and Exemptions

8/19/2015 to 8/20/2015
When: August 19-20, 2015
Where: The Desmond Hotel and Conference Center
1 Liberty Blvd
Malvern, Pennsylvania  19355
United States
Presenter: The Center for Professional Innovation & Education, Inc.
Contact: Olivia Carlin
610-648-7550

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Introduction to Medical Device Submissions – 510(k)s, PMAs, and Exemptions

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.

Learn more about the course and register.

CfPIE is a preferred provider and offers MichBio members a 15% discount on course registration fees. Click here for more information.

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