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DTSTAMP:20260506T135621Z
SUMMARY:FDA Device Software Regulation
DESCRIPTION:Overview:\nSoftware's level of complexity and use is expan
 ding at exponential levels. Likewise the potential risks to health fol
 low suit. Problems with software create a number of different hurdles.
  Software may be a standalone device, control a device's performance, 
 make calculations, identify treatment options or begin to play a more 
 active role in making clinical decisions regarding patient management 
 and treatment.FDA's risk classification will gradually clarify how it 
 intends to manage the health risks. Software use has become increasing
 ly complicated with the expansion of software applications, for exampl
 e: cybersecurity, interoperability, mobile medical \"apps,\" home use 
 and remote use. Another growing concern is the public's use of softwar
 e programs to manage their health issues rather than go to a healthcar
 e professional. The increasing sophistication and venue for use creat
 e new software design validation considerations. In many instances, va
 lidation is limited to the immediate use of the software rather than i
 ts environment of use, its performance with other software programs an
 d software hacking. When software causes a problem, fixing the malfunc
 tion or \"bug\" may be more difficult as software becomes more sophist
 icated, customized by users and placed in a network system. In these k
 inds of circumstances, it is difficult to decide who is responsible fo
 r managing and fixing the software problems. This becomes a major regu
 latory headache for FDA and generates business to business conflicts. 
 When firms are designing and marketing software, they should be mindfu
 l the unknowns that lurk in the future of software regulated as a devi
 ce by FDA. Why should you Attend: For decades, firms have experience
 d serious problems with software and have been at a loss to make a wel
 l informed follow up. Software problems represent one of the most comm
 on root causes for recalls. Software failures have been associated wit
 h deaths and serious injuries beyond what is necessary to quantify. FD
 A sees firms revise software only to have it create more problems rath
 er than solve them. The infusion pump industry is a classic example. 
 The growth of the medical software industry outpaces how FDA's regulat
 ory process is designed. How can you anticipate and defend against the
  malicious remote hacking and shut down of an insulin infusion pump? I
 n some instances clinicians have weighed the risk of software failure 
 against the benefits of using a device at all. Device software is ofte
 n used in conjunction with other software based devices, but their int
 eroperability was never anticipated. Can one software program defeat t
 he performance capability or back up safety features of another softwa
 re program? When interoperability surface, which software manufacturer
  takes the lead to solve the problem and deal with proprietary softwar
 e issues? These are the kinds of issues that will be highlighted duri
 ng the webinar. The issues require careful consideration even though n
 o obvious answer appears at hand. Areas Covered in the Session:\n\nFD
 A legal authority\nFDA software guidance\nCybersecurity\nInteroperabil
 ity\nMobile Apps\nRecalls\n\nWho Will Benefit:\n\nRegulatory Affairs\n
 Quality Assurance\nSoftware Design Engineers\nManufacturing\nComplaint
  Dept.\nHospital Risk Dept.\n\nCLICK HERE\n\nFor more information visi
 t https://medtechiq.ning.com/events/fda-device-software-regulation
DTSTART;TZID=America/New_York:20140729T100000
DTEND;TZID=America/New_York:20140729T110000
CATEGORIES:seminar, pharma, medical, clinical, health, compliance, reg
 ulatory, fda
LOCATION:Online Event
WEBSITE:http://bit.ly/1kDHIj8
URL:http://bit.ly/1kDHIj8
CONTACT:8004479407
ORGANIZER:GlobalCompliancePanel
ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/
 file/get/2562011671?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="John Rob
 inson":https://medtechiq.ning.com/profile/JohnRobinson
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