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DTSTART:19700308T020000
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UID:2140535:Event:80134
DTSTAMP:20260524T051024Z
SUMMARY:Medical Device Hazard Analysis (ISO 14971)
DESCRIPTION:Overview:This is the most powerful of the risk management 
 techniques because it considers risks in normal operation as well as f
 ault conditions. FMEA and FTA consider only fault conditions and are m
 ore suited as reliability tools than as product safety tools.\nWhy sho
 uld you Attend:FDA expects that as part of a product development progr
 am risk management will be conducted. Hazard Analysis is the most powe
 rful of the risk management tools described in ISO 14971 but it is ver
 y confusing. Many new concepts are introduced. we will explain these c
 oncepts and provide examples so that the process is clear.\nAreas Cove
 red in the Session:Explanation of Hazard Analysis termsHazard Analysis
  Process Explanation using a TemplateExamples of Terms will be givenHa
 zard Analysis Examples will be Covered Step by Step\nWho Will Benefit:
 EngineerEngineering ManagerRegulatory PersonnelQA\nSpeaker Profile:Edw
 in Waldbusser is a consultant retired from industry after 20 years in 
 management of development of medical devices (5 patents). He has been 
 consulting in the US and internationally in the areas of design contro
 l, risk analysis and software validation for the past 8 years. Mr. Wal
 dbusser has a BS in Mechanical Engineering and an MBA. He is a Lloyds 
 of London certified ISO 9000 Lead Auditor and a member of the Thomson 
 Reuters Expert Witness network.\nEvent Fee: One Dial-in One Attendee P
 rice: US $150.00\nContact Detail:Compliance4All DBA NetZealous,Phone: 
 +1-800-447-9407Email: support@compliance4All.com\n\nFor more informati
 on visit https://medtechiq.ning.com/events/medical-device-hazard-analy
 sis-iso-14971
DTSTART;TZID=America/New_York:20181002T100000
DTEND;TZID=America/New_York:20181002T110000
CATEGORIES:webinar
LOCATION:Online
WEBSITE:https://www.compliance4all.com/control/w_product/~product_id=5
 02035LIVE?channel=medtechiq_Oct_2018_SEO
URL:https://www.compliance4all.com/control/w_product/~product_id=50203
 5LIVE?channel=medtechiq_Oct_2018_SEO
CONTACT:Event Manager
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/2562019319?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="Adam Fle
 ming":https://medtechiq.ning.com/profile/Compliance4all
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