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DTSTAMP:20260412T163209Z
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.\nThe medical device trade and healthc
 are professionals remain plagued by other issues, such as the interope
 rability of devices from different manufacturers, or software validati
 on that is limited to the immediate use of the software rather than it
 s performance with other software programs, and software hacking prote
 ction applications. In case of software malfunction, fixing the malfun
 ction or bug can get more difficult as software gets increasingly soph
 isticated, customized by users and placed in a network system. Under t
 hese circumstances, it is difficult to decide who is responsible for m
 anaging and fixing software problems.\nThis seminar will help those in
 volved in overcoming these commercial and regulatory obstacles. It wil
 l highlight the need for firms to remain current with technological to
 ols and strategy to remain competitive, and ideally, outside FDA’s r
 egulatory radar. Going further, it will instruct participants on how t
 o apply these tools and strategies to ensure the following factors:\n\
 nSoftware functionality\nRisk identification\nSoftware protection\nPro
 blem detection\nResponse strategy\n\nFor those who have addressed thes
 e issues to meet FDA’s regulatory expectations, the course instructo
 r, a former FDA official, will help identify a basic centering point t
 o build a regulatory profile for your software products.\nLearning Obj
 ectives:\n\nUnderstanding FDA legal authority\nApplying FDA classifica
 tions / risk controls\nUnderstanding FDA and NIST software guidance\nI
 dentifying the quality system regulation for risk management, software
  verification and validation\nIdentifying cybersecurity issues and dev
 eloping a planned response\nIdentifying and resolving interoperability
  issues\nFiguring out the scope of FDA’s mobile apps regulation\nLea
 rning about bug updates classified as recalls by FDA\nFuture device so
 ftware applications\n\nWho Will Benefit:\n\nRegulatory Affairs Manager
 s\nQuality Assurance Managers\nSoftware Design Engineers\nManufacturin
 g Managers\nCompliance Department Personnel\nHospital Risk Department 
 Personnel\nSoftware Program Marketers\nIT Security Managers\nMarketing
  Personnel\n\n\nFor more information visit https://medtechiq.ning.com/
 events/fda-s-medical-device-software-regulation-strategy
DTSTART;TZID=America/New_York:20210209T083000
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
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 /file/get/8294169064?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=Complianc
 eOnline:https://medtechiq.ning.com/profile/Referral512
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