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:66509 DTSTAMP:20260530T163147Z SUMMARY:Product Risk Management - ISO 14971:2007 DESCRIPTION:Overview: \nThis webinar will address the use of the ISO 14971 model to perform and document such activities and the additional actions necessary to make it a useful product reference and training tool.\nThe U.S. FDA has stated that the use of a medical device entail s some degree of risk. In fact, any medical procedure / intervention does. A manufacturer is responsible to identify those risks, and ta ke reasonable steps to mitigate them as far as practical and given the 'state of the art' at the time. ISO 14971 provides an accepted vehi cle by which to perform and document such an analysis and is accepted by the FDA. These activities can also be used as a method to train n ew hires, especially in Marketing, QA/RA, Engineering, and Manufacturi ng. Areas Covered in the Session:\n\nThe Revised ISO 14971:2007\nProd uct Hazard Analysis\nDesign, Process, and Use[r] Failure Mode, Effects and Criticality Analysis\nFault Tree Analysis\nThe Team and It's Invo lvement – Who, When and How\nProduct Risk Management File and R eport\nUsing the Completed Document – It’s Real Value\nK eeping it \"In the Loop\"\nA \"Living Document\" \n\nCompliance4AllAd am FleamingPhone: +1-800-447-9407 support@compliance4all.comwww.compli ance4all.comEvent Link :http://www.compliance4all.com/control/w_produc t/~product_id=500445LIVE/\n\nFor more information visit https://medtec hiq.ning.com/events/product-risk-management-iso-14971-2007 DTSTART;TZID=America/New_York:20150930T100000 DTEND;TZID=America/New_York:20150930T110000 CATEGORIES:webinar LOCATION:Online Event WEBSITE:http://www.compliance4all.com/control/w_product/~product_id=50 0445LIVE/ URL:http://www.compliance4all.com/control/w_product/~product_id=500445 LIVE/ CONTACT:8004479407 ORGANIZER;CN="Adam Fleming":https://medtechiq.ning.com/profile/Complia nce4all ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/ file/get/2562012364?profile=original END:VEVENT END:VCALENDAR