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DTSTAMP:20260413T113818Z
SUMMARY:Guidance on Software and Device Changes and the 510(k)
DESCRIPTION:Overview: The first guidance document clarifies key terms 
 and provides insight as to how a risk assessment can help medical devi
 ce manufacturers to evaluate whether a new 510(k) is required.\nWhy sh
 ould you Attend:Anyone who is involved in software and device design, 
 modification, manufacturing, quality testing and distribution should b
 e aware of these changes and the impact on decision-making as to wheth
 er or not to prepare a new 510(k). The FDA provides flowcharts that gu
 ide the reader to the best decision, but some judgment is also require
 d.\nAreas Covered in the Session:Medical Device changesSoftware Applic
 ation changes for software used in conjunction with medical devicesFDA
  Guidance DocumentsFDA EnforcementNew 510(k) submission\nWho Will Bene
 fit:Information Technology (IT) AnalystsIT DevelopersIT Support StaffQ
 C/QA Managers and AnalystsClinical Data Managers and ScientistsAnalyti
 cal Chemists\nSpeaker Profile:Carolyn (McKillop) Troiano Carolyn Troia
 no has more than 35 years of experience in the tobacco, pharmaceutical
 , medical device and other FDA-regulated industries. She has worked di
 rectly, or on a consulting basis, for many of the larger pharmaceutica
 l and tobacco companies in the US and Europe, developing and executing
  compliance strategies and programs.\nContact Detail:Compliance4All DB
 A NetZealous,Phone: +1-800-447-9407Email: support@compliance4All.com\n
 \nFor more information visit https://medtechiq.ning.com/events/guidanc
 e-on-software-and-device-changes-and-the-510-k
DTSTART;TZID=America/New_York:20171030T100000
DTEND;TZID=America/New_York:20171030T110000
CATEGORIES:webinar
LOCATION:Online
WEBSITE:http://www.compliance4all.com/control/w_product/~product_id=50
 1507LIVE?channel=medtechiq_Oct_2017_SEO
URL:http://www.compliance4all.com/control/w_product/~product_id=501507
 LIVE?channel=medtechiq_Oct_2017_SEO
CONTACT:18004479407
ORGANIZER:Event Manager
ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/
 file/get/2562015853?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="Adam Fle
 ming":https://medtechiq.ning.com/profile/Compliance4all
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