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:468665
DTSTAMP:20260412T192935Z
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.\n\nThe medical device trade and healt
 hcare professionals remain plagued by other issues, such as the intero
 perability of devices from different manufacturers, or software valida
 tion that is limited to the immediate use of the software rather than 
 its performance with other software programs, and software hacking pro
 tection applications. In case of software malfunction, fixing the malf
 unction or bug can get more difficult as software gets increasingly so
 phisticated, customized by users and placed in a network system. Under
  these circumstances, it is difficult to decide who is responsible for
  managing and fixing software problems.\n\nLearning Objectives:\n\nUnd
 erstanding FDA legal authority\nApplying FDA classifications / risk co
 ntrols\nUnderstanding FDA and NIST software guidance\nIdentifying the 
 quality system regulation for risk management, software verification a
 nd validation\nIdentifying cybersecurity issues and developing a plann
 ed response\nIdentifying and resolving interoperability issues\nFiguri
 ng out the scope of FDA’s mobile apps regulation\nLearning about bug
  updates classified as recalls by FDA\nFuture device software applicat
 ions\n\nWho Will Benefit:\n\nRegulatory Affairs Managers\nQuality Assu
 rance Managers\nSoftware Design Engineers\nManufacturing Managers\nCom
 pliance Department Personnel\nHospital Risk Department Personnel\nSoft
 ware Program Marketers\nIT Security Managers\nMarketing Personnel\n\n\
 nFor more information visit https://medtechiq.ning.com/events/fda-s-me
 dical-device-software-regulation-strategy-2
DTSTART;TZID=America/New_York:20210610T083000
DTEND;TZID=America/New_York:20210611T143000
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/8958858088?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=Complianc
 eOnline:https://medtechiq.ning.com/profile/Referral512
END:VEVENT
END:VCALENDAR