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DTSTART:19700308T020000
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UID:2140535:Event:62122
DTSTAMP:20260525T021607Z
SUMMARY:Secrets to Preventing Medical Device Recalls
DESCRIPTION:This webinar on preventing medical device recalls will cov
 er strategies such as writing good specification, design reviews, tool
 s for identifying sources of hazards, including embedded software haza
 rds and more. It presents examples and secret tips from the presenterâ
 €™s experience of over 30 years in the medical device and aerospace in
 dustry\nWhy Should You Attend:\nThe number of FDA product recalls per 
 year is currently is at all time high especially with devices containi
 ng embedded software. The FDA received more than 10,000 complaints per
  year on infusion pumps alone during this period. Some pump manufactur
 ers say that most problems occur when a nurse or health care worker en
 ters the wrong data accidentally. However, FDA officials found that ma
 ny deaths and injuries related to the devices were caused by product d
 esign and engineering flaws, rather than user errors.\nThis webinar co
 vers paradigms for proactive thinking and doing. It will show how to m
 itigate for user errors in the design of medical devices. Participants
  will learn to follow good evidence based design control, production v
 alidation, and accelerated test methodologies to prevent recalls. The 
 presenter will highlight examples from his experience and use case stu
 dies to teach you strategies and interesting secrets that will be valu
 able in helping you prevent device recalls.\nAreas Covered in the Webi
 nar:\n\nOverview of FDA Quality System Regulation\nOverview of ISO 149
 71\nWriting good specification to avoid many sources of product flaws\
 nDesign reviews for identifying potential recalls\nTools for identifyi
 ng sources of hazards\nFault Tree Analysis to identify dangers in comp
 lex devices\nIdentifying software hazards\nDeveloping a recall prevent
 ion program\n\n\nFor more information visit https://medtechiq.ning.com
 /events/secrets-to-preventing-medical-device-recalls
DTSTART;TZID=America/New_York:20130816T100000
DTEND;TZID=America/New_York:20130816T113000
CATEGORIES:medical, device, webinar
LOCATION:Online Event
WEBSITE:http://www.complianceonline.com/ecommerce/control/trainingFocu
 s/~product_id=703057?channel=medtechiq
URL:http://www.complianceonline.com/ecommerce/control/trainingFocus/~p
 roduct_id=703057?channel=medtechiq
CONTACT:+1-650-620-3915
ORGANIZER;CN=Referral:https://medtechiq.ning.com/profile/Referral
ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/
 file/get/2562006570?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=Referral:
 https://medtechiq.ning.com/profile/Referral
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