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DTSTART:19700308T020000
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UID:2140535:Event:65552
DTSTAMP:20260520T122744Z
SUMMARY:Webinar Medical Device Changes and the 510(k)
DESCRIPTION:This webinar will provide valuable guidance to regulated c
 ompanies in development and implementation of formal, defined, documen
 ted methods for analysis of product changes and when to file a new 510
 (k). Consideration of the U.S. FDA's current K-97-1 Memo / guidance do
 cument on \"510(k) Device Modifications\"\n\nAreas Covered in the Sess
 ion :\nThis webinar will provide valuable assistance to all regulated 
 companies performing and documenting meaningful, results driven 510(k)
  / change analysis activities, based on the FDA's current Guidance on 
 510(k) Device Modifications. This session will cover:\nDeciding When t
 o Submit a 510(k) for a Change to an Existing Device, K97-1\nHow to pr
 ovide tools to document such decisions\nIt will discuss how companies 
 can best document their decisions -- whether or not a new 510(k) filin
 g is warranted\nHow to structure a decision matrix to document change 
 decisions\nHow to evaluate changes that could trigger the \"Tipping Po
 int\"\nWho makes the decisions and how to defend them\nHow to implemen
 t formal methods with documented, and defensible rationale\nPreparing 
 for further 510(k) changes in the future\nWho Will Benefit:\nThis webi
 nar is a must for companies in the Medical Device and combination prod
 ucts fields. The employees who will benefit include:\nResearch & Devel
 opment\nEngineering Staff\nQuality Assurance\nRegulatory Affairs\nLean
  & Six Sigma staff\nNew Product Development\nMarketing\nMid-level and 
 Senior Management\nProject Leaders\nConsultants\nPrice tags:\nLive\nSi
 ngle Live : For One Participant\n$ 249\nCorporate Live : For Max. 10 P
 articipants\n$ 899\nRecording\nSingle REC : For One Participant - Unli
 mited Access for 6 Months\n$ 299\nFor more information and enquiries c
 ontact us at\nCompliance Trainings\n5939 Candlebrook Ct, Mississauga, 
 ON L5V 2V5, Canada\nCustomer Support : #416-915-4458\nEmail : support@
 compliancetrainings.com\nFor more information about this event please 
 visit\nhttps://compliancetrainings.com/SiteEngine/ProductDetailView.as
 px?id=MD1541\nLike Us On Facebook:\nhttps://www.facebook.com/events/78
 4546744972359\n\nFor more information visit https://medtechiq.ning.com
 /events/webinar-medical-device-changes-and-the-510-k
DTSTART;TZID=America/New_York:20170703T130000
DTEND;TZID=America/New_York:20170703T143000
CATEGORIES:webinar
LOCATION:Online
WEBSITE:http://bit.ly/1GxlecB
URL:http://bit.ly/1GxlecB
CONTACT:4169154458
ORGANIZER:Compliance Trainings
ATTACH;FMTTYPE="image/jpeg":
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=complianc
 etrainings:https://medtechiq.ning.com/profile/compliancetrainings
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