BEGIN:VCALENDAR
PRODID:NingEventWidget-v1
VERSION:2.0
METHOD:PUBLISH
BEGIN:VTIMEZONE
TZID:America/New_York
X-LIC-LOCATION:America/New_York
BEGIN:DAYLIGHT
TZOFFSETFROM:-0500
TZOFFSETTO:-0400
TZNAME:EDT
DTSTART:19700308T020000
RRULE:FREQ=YEARLY;BYMONTH=3;BYDAY=2SU
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:-0400
TZOFFSETTO:-0500
TZNAME:EST
DTSTART:19701101T020000
RRULE:FREQ=YEARLY;BYMONTH=11;BYDAY=1SU
END:STANDARD
END:VTIMEZONE
BEGIN:VEVENT
UID:2140535:Event:66392
DTSTAMP:20260522T005604Z
SUMMARY:Device Changes, FDA Changes, and the 510(k)
DESCRIPTION:Overview: \nThe majority of medical devices are cleared 
 for marketing in the U.S. by the FDA under the 510(k) process. The FDA
  holds companies responsible for filing new 510(k)s when one change is
  major enough to impact safety / effectiveness, or when a series of le
 sser changes finally reach the \"tipping point\".\nThis is a major hea
 dache. How can companies make that determination? How can they trigger
  such an analysis over the major change or the series of smaller chang
 es. What approaches are required for product changes; for process chan
 ges. How is the process risk-based? How to maximize the process agains
 t scarce resources. What are the different considerations for CE-marke
 d product?Areas Covered in the Session:\n\nU.S. FDA device clearance /
  approval\nFDA's and EU's emphasis\nProduct changes and filing a new 5
 10(k) - who's responsible\nTracking and evaluating changes - the \"tip
 ping point\"\nIs the process \"risk based\"?\nK-97-1 and the FDA's \"D
 ecision Tree\"\nDocumenting the process / rationale\nResolving a \"wro
 ng decision\" \n\nCompliance4AllAdam FleamingPhone: +1-800-447-9407 s
 upport@compliance4all.comwww.compliance4all.comEvent Link :http://www.
 compliance4all.com/control/w_product/~product_id=500444LIVE\n\nFor mor
 e information visit https://medtechiq.ning.com/events/device-changes-f
 da-changes-and-the-510-k
DTSTART;TZID=America/New_York:20150909T100000
DTEND;TZID=America/New_York:20150909T110000
CATEGORIES:webinar
LOCATION:Online Event
WEBSITE:http://www.compliance4all.com/control/w_product/~product_id=50
 0444LIVE
URL:http://www.compliance4all.com/control/w_product/~product_id=500444
 LIVE
CONTACT:8004479407
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/2562012364?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="Adam Fle
 ming":https://medtechiq.ning.com/profile/Compliance4all
END:VEVENT
END:VCALENDAR