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UID:2140535:Event:79940
DTSTAMP:20260523T200252Z
SUMMARY:FDA New Draft Guidance on (Software) and Device Changes 510k
DESCRIPTION:Overview:A 510(k) is a premarket submission made to FDA to
  demonstrate that the device to be marketed is at least as safe and ef
 fective, that is, substantially equivalent, to a legally marketed devi
 ce (21 CFR 807.92(a)(3)) that is not subject to PMA.\nWhy should you A
 ttend:This includes any major change or modification to the intended u
 se of the device that could have an impact on patient safety and effec
 tiveness. After attending this webinar, you will be able to better nav
 igate the processes required to determine how to manage software and d
 evice changes in an FDA-compliant manner.\nAreas Covered in the Sessio
 n:Medical Device changesSoftware Application changes for software used
  in conjunction with medical devicesFDA Guidance DocumentsFDA Enforcem
 entNew 510(k) submissionSubstantial Equivalence\nWho Will Benefit:Info
 rmation Technology (IT) AnalystsIT DevelopersIT Support StaffQC/QA Man
 agers and AnalystsClinical Data Managers and ScientistsAnalytical Chem
 istsQuality Managers, Chemists and MicrobiologistsCompliance Managers 
 and AuditorsLab Managers and Analysts\nSpeaker Profile:Carolyn (McKill
 op) Troiano has more than 35 years of experience in the tobacco, pharm
 aceutical, medical device and other FDA-regulated industries. She has 
 worked directly, or on a consulting basis, for many of the larger phar
 maceutical and tobacco companies in the US and Europe, developing and 
 executing compliance strategies and programs. Carolyn is currently act
 ive in the Association of Information Technology Professionals (AITP),
  and Project Management Institute (PMI) chapters in the Richmond, VA a
 rea.\nEvent Fee: One Dial-in One Attendee Price: US $290.00\nContact D
 etail:Compliance4All DBA NetZealous,Phone: +1-800-447-9407Email: suppo
 rt@compliance4All.com\n\nFor more information visit https://medtechiq.
 ning.com/events/fda-new-draft-guidance-on-software-and-device-changes-
 510k
DTSTART;TZID=America/New_York:20181012T090000
DTEND;TZID=America/New_York:20181012T120000
CATEGORIES:webinar
LOCATION:Online
WEBSITE:https://www.compliance4all.com/control/w_product/~product_id=5
 02118LIVE?channel=medtechiq_Oct_2018_SEO
URL:https://www.compliance4all.com/control/w_product/~product_id=50211
 8LIVE?channel=medtechiq_Oct_2018_SEO
CONTACT:Event Manager
ORGANIZER;CN="Adam Fleming":https://medtechiq.ning.com/profile/Complia
 nce4all
ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/
 file/get/2562017395?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="Adam Fle
 ming":https://medtechiq.ning.com/profile/Compliance4all
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