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DTSTART:19700308T020000
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UID:2140535:Event:452442
DTSTAMP:20260413T143944Z
SUMMARY:FDA's Medical Device Software Regulation Strategy
DESCRIPTION:The growth of the medical software industry outpaces the d
 esign of FDA's regulatory process. In some instances clinicians have w
 eighed the risk of software failure against the benefits of using a de
 vice at all. Device software is often used in conjunction with other s
 oftware-based devices, but their interoperability was never anticipate
 d.\n\nHow can you anticipate and defend against the malicious remote h
 acking and shut down of an insulin infusion pump?\nCan one software pr
 ogram defeat the performance capability or back up safety features of 
 another software program?\nWhen interoperability surface, which softwa
 re manufacturer takes the lead to solve the problem and deal with prop
 rietary software issues?\n\nThis seminar will focus on addressing thes
 e concerns and educating participants on FDA’s recent medical device
  software regulation strategies.\nThis seminar will help those involve
 d in overcoming these commercial and regulatory obstacles. It will hig
 hlight the need for firms to remain current with technological tools a
 nd strategy to remain competitive, and ideally, outside FDA’s regula
 tory radar. Going further, it will instruct participants on how to app
 ly these tools and strategies to ensure the following factors:\n\nSoft
 ware functionality\nRisk identification\nSoftware protection\n\n\nFor 
 more information visit https://medtechiq.ning.com/events/fda-s-medical
 -device-software-regulation-strategy-1
DTSTART;TZID=America/New_York:20210209T203000
DTEND;TZID=America/New_York:20210210T143000
CATEGORIES:seminae
LOCATION:online
WEBSITE:https://www.complianceonline.com/fda-medical-device-software-r
 egulation-strategy-seminar-training-by-ex-fda-official-seminar-trainin
 g-80242SEM-prdsm?channel=MedTech%20I.Q
URL:https://www.complianceonline.com/fda-medical-device-software-regul
 ation-strategy-seminar-training-by-ex-fda-official-seminar-training-80
 242SEM-prdsm?channel=MedTech%20I.Q
CONTACT:8887172436
ORGANIZER;CN=ComplianceOnline:https://medtechiq.ning.com/profile/Refer
 ral512
ATTACH;FMTTYPE="image/jpeg":https://storage.ning.com/topology/rest/1.0
 /file/get/8493803861?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=Complianc
 eOnline:https://medtechiq.ning.com/profile/Referral512
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