Conferences
Conference Details
This 3 hour Webinar is a primer and overview to the premarket notification process, i.e., a 510(k). A 510(k) is a premarket submission made to FDA to demonstrate that your device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to PMA
Date :
Place : United States, Fremont
Website :http://www.compliance4all.com/control/w_product/~product_id=500394LIVE/
Contact Person:Adam Fleaming
Description:
This 3 hour Webinar is a primer and overview to the premarket notification process, i.e., a 510(k). A 510(k) is a premarket submission made to FDA to demonstrate that your device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to PMAThis 3 hour Webinar is a primer and overview to the premarket notification process, i.e., a 510(k). A 510(k) is a premarket submission made to FDA to demonstrate that your device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to PMA will be held in Fremont,United States on date 2015-09-01
Deadline for abstracts/proposals : 31st August 2015
Organized By :Compliance4All
Keynote Speakers : David R. Dills, Regulatory Affairs & Compliance Consultant currently provides regulatory, compliance and quality consultative services for medical device and pharmaceutical/combination manufacturers, and also has an accomplished record with more than 24 years of experience with Class I/II/III medical devices, In Vitro diagnostics, and pharmaceuticals in the areas of Regulatory Affairs, Compliance and Quality Systems. He has been previously employed, with increasing responsibilities by medica
Conference Highlights :Know the differences between the Traditional, Special and Abbreviated submissions Understand Substantial Equivalence and how it is applied Who is required to submit the application to FDA Where to submit the 510(k) and what to expect with the review and approval process When it is and is not required if you are a device company Exemptions to the submission process and special considerations How to locate a "predicate" device and go through the content and format of the 510(k) Un
Venue :online event
Check the event website for more details.
.jpg "This 3 hour Webinar is a primer and overview to the premarket notification process, i.e., a 510(k). A 510(k) is a premarket submission made to FDA to demonstrate that your device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to PMA")
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