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DTSTART:19700308T020000
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UID:2140535:Event:72807
DTSTAMP:20260521T142229Z
SUMMARY:Latest FDA Changes to the Process Bullet Proof 510k - 2017
DESCRIPTION:Overview:  The Special and Abbreviated 510(k) methods wer
 e developed under the \"New 510(k) Paradigm\" to help streamline the 5
 10(k) review process. Objectives:    Know the differences between t
 he Traditional, Special and Abbreviated submissions    Understand S
 ubstantial Equivalence and how it is applied    Who is required to 
 submit the application to FDA Who Will Benefit:This course is appropri
 ate to those involved in all aspects of the premarket notification, i.
 e., 510(k) process on behalf of medical device and In Vitro Diagnostic
  manufacturers.Speaker Profile:David R. Dills,Global Regulatory Affair
 s & Compliance Consultant currently provides regulatory affairs and co
 mpliance consultative services for early-stage and established Class I
 /II/III device, IVD, biopharmaceutical, cosmetics and nutraceutical ma
 nufacturers on the global landscape.Contact Detail:Compliance4All DBA 
 NetZealous,Phone: +1-800-447-9407Email: support@compliance4All.com\n\n
 For more information visit https://medtechiq.ning.com/events/latest-fd
 a-changes-to-the-process-bullet-proof-510k-2017
DTSTART;TZID=America/New_York:20170725T100000
DTEND;TZID=America/New_York:20170725T110000
CATEGORIES:webinar
LOCATION:Online
WEBSITE:http://www.compliance4all.com/control/w_product/~product_id=50
 1323LIVE?channel=medtechiq.ning_Jul_2017_SEO
URL:http://www.compliance4all.com/control/w_product/~product_id=501323
 LIVE?channel=medtechiq.ning_Jul_2017_SEO
CONTACT:18004479407
ORGANIZER:Netzealous LLC DBA - Compliance4All
ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/
 file/get/2562015210?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="Adam Fle
 ming":https://medtechiq.ning.com/profile/Compliance4all
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