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2018 - Medical Device Hazard Analysis (ISO 14971)



VenueFremont, USA - United States USA - United States

KeywordsEngineer; Engineering Manager; Compliance trainings


Topics/Call fo Papers

This is the most powerful of the risk management techniques because it
considers risks in normal operation as well as fault conditions. FMEA and
FTA consider only fault conditions and are more suited as reliability tools
than as product safety tools.
Why should you Attend:
FDA expects that as part of a product development program risk
management will be conducted. Hazard Analysis is the most powerful of
the risk management tools described in ISO 14971 but it is very
confusing. Many new concepts are introduced. we will explain these
concepts and provide examples so that the process is clear.
Areas Covered in the Session:
Explanation of Hazard Analysis terms
Hazard Analysis Process Explanation using a Template
Examples of Terms will be given
Hazard Analysis Examples will be Covered Step by Step
Who Will Benefit:
Engineering Manager
Regulatory Personnel
Speaker Profile:
Edwin 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 control, risk
analysis and software validation for the past 8 years. Mr. Waldbusser 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.
Event Fee: One Dial-in One Attendee Price: US $150.00
Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407

Last modified: 2018-08-10 14:25:08