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:66064 DTSTAMP:20260529T124245Z SUMMARY:Software Risk Analysis Tools for Medical Devices and Risk Miti gation at Chicago DESCRIPTION:Overview:\nThe FDA recalls related to software performance are on the increase for at least five years at the time of this writi ng. Software failures were behind 24 percent of all the medical device recalls in 2011, according to data from the FDA. Similar to hardware, software also has hazards (any source of harm) and hazardous situatio ns which transform a hazard into harm. We must identify hazards and id entify what event can turn them into harm and write software specifica tions to prevent such combinations. The risk management tools such as FMEA (Failure Mode and Effects Analysis), FTA (Fault Tree Analysis) ca n help to mitigate software risks. These tools are covered in the Chap ter 4. The mitigations from using the tools become the new requirement s in the software specification \nWhy should you attend?\nYou have to do risk analysis using the tools in ISO 14971. It is one of the first things FDA will ask for! It is required by law (21 CFR Section 820) a nd appears on regulatory submission checklists. In addition, it will h elp define validation that should be done to prove the safety of your actual device use. You can also eliminate costs associated with recall s and lawsuits.\nAreas Covered in the:\n\nOverview of ISO 14971\nOverv iew of IEC 63204\nThe best tools for risk analysis\nApplication of too ls such as PHA,FMEA,FTA\nIdentifying missing requirements in specifica tions\nIntelligent problem fixing before they happen\nParadigms for ef ficiency and efficacy of risk control\nWorld class best practices in r isk analysis\nAccounting for risks from unintended use and misuse\nCas e histories\n\nWho Will Benefit:\n\nAll Senior Managers\nSoftware Engi neers and Managers\nAll Hardware Engineers and Managers\nSoftware team Leaders\nR&D Staff\nSoftware Testers\nQuality Assurance Staff\nRegula tory Staff\nMarketing Staff\nServicing Staff\nProduct Safety Staff\n\n Speaker:\nDev Raheja, MS,CSP, author of the books Preventing Medical Device Recalls and Safer Hospital Care, is an international risk man agement, patient safety and quality assurance consultant for medical d evice, healthcare and aerospace industry for over 25 years. Prior to b ecoming a consultant in 1982 he worked at GE Healthcare as Supervisor of Quality Assurance/Manager of Manufacturing Engineering, at Cooper I ndustries as Chief Engineer, and at Booz-Allen & Hamilton as Risk Mana gement consultant for variety of industries. \nPrice: $1,295.00 (Semi nar for One Delegate)\nRegister now and save $200. (Early Bird)\nUntil July 10, Early Bird Price: $1,295.00\nFrom July 11 to August 18, Regu lar Price: $1,495.00\nContact Information:\nNetZealous LLC,\nDBA Globa lCompliancePanel\n161 Mission Falls Lane, Suite 216, Fremont, CA 94539 , USA         \nUSA Phone: 800-447-9407\nFax: 302-288-6884\ns upport@globalcompliancepanel.com          \nhttp://www.globa lcompliancepanel.com\nEvent Registration Link – http://bit.ly/1bkF80 b\n\nFor more information visit https://medtechiq.ning.com/events/soft ware-risk-analysis-tools-for-medical-devices-and-risk DTSTART;TZID=America/New_York:20150820T090000 DTEND;TZID=America/New_York:20150821T180000 CATEGORIES:clinical, food, fda, medical, device, defence, and, navy, a erospace, mining LOCATION:Courtyard Chicago O'Hare WEBSITE:https://www.globalcompliancepanel.com URL:https://www.globalcompliancepanel.com CONTACT:18004479407 ORGANIZER:GlobalCompliancePanel ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/ file/get/2562011438?profile=original ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="John Rob inson":https://medtechiq.ning.com/profile/JohnRobinson END:VEVENT END:VCALENDAR