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UID:2140535:Event:60772
DTSTAMP:20260524T215214Z
SUMMARY:An Easy to Implement Integrated Risk Management Approach Compl
 iant with ISO 14971
DESCRIPTION:This integrated risk management training for medical devic
 es will discuss how to incorporate risk management as per ISO 14971 gu
 idelines in all phases of medical device development. It will highligh
 t the documentation needed to support the decisions made as part of th
 e risk management process.\nWhy Should You Attend:\nISO 14971 Medical 
 devices - Application of risk management to medical devices is a volun
 tary standard that medical device manufacturers must incorporate into 
 their design and development process in order to ensure medical device
 s designed are safe and effective. The FDA now also recognizes ISO1497
 1, and can audit to it if manufacturer's claim they conform to it. Alt
 hough ISO 14971 has been in place since 1998, many companies still fin
 d it difficult to properly interpret the requirements of the standards
  and having a risk management process which is not helpful in designin
 g robust, safe medical devices.\nThis webinar will cover all major ele
 ments of ISO 14971 and present a methodology for integrating the requi
 rements of this standard into the product development process to ensur
 e that the requirements of the standard are met, and the medical devic
 e is designed to be safe and effective. The webinar will specify how r
 isk management activities are incorporated in all phases of developmen
 t, and what supporting documentation needs to be gathered in order to 
 ensure that decisions made based on what is learned as part of the ris
 k management process are adequately justified and documented.\nAreas C
 overed in the Seminar:\n\nHow are risk management activities integrate
 d throughout the development process.\nThe roles that Hazard Analysis,
  FTA, FMEA, HAZOP and PFMEA play in an Integrated Risk Management Proc
 ess.\nHow to control and verify risk mitigations.\nHow to perform a Ri
 sk Benefit Analysis on ALARP and INTOLARABLE Hazards.\nThe importance 
 of maintaing Risk Management documents in the Post Production era.\nWh
 at information to include in the Risk Management Plan and Report for b
 etter auditability.\n\n\nFor more information visit https://medtechiq.
 ning.com/events/an-easy-to-implement-integrated-risk-management-approa
 ch
DTSTART;TZID=America/New_York:20130723T100000
DTEND;TZID=America/New_York:20130723T111500
CATEGORIES:medical, device, webinar
LOCATION:Online Event
WEBSITE:http://www.complianceonline.com/ecommerce/control/trainingFocu
 s/~product_id=701773?channel=medtechiq
URL:http://www.complianceonline.com/ecommerce/control/trainingFocus/~p
 roduct_id=701773?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/2562006613?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=Referral:
 https://medtechiq.ning.com/profile/Referral
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