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| Course Title: |
Regulatory Requirements for Medical Devices course |
| School: |
University of California, Irvine
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| Description: |
Increase your understanding of the essential U.S. medical device regulations, including device classification, organizing pre-market notification 510(k), and planning and submitting a Pre-market approval (PMA). Enhance your knowledge of topics that include: global vigilance requirements and labeling requirements, European Medical Device Directive 93/42/EEC (MDD), E.U. conformity assessments, meeting E.U. essential requirements, and developing a technical file for the E.U. Get a review of device registrations in Canada, Australia, Japan and Latin America. |
| Learning Format: |
Online or on-campus
(?)
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| Education Level: |
Continuing Education |
| Language: |
English |
Cost: |
$685 |
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