Medical Device Hazard Analysis (ISO 14971)

MessageThis Webinar is over
Date Oct 2, 2018
Time 10:00 AM to 11:00 AM
Cost 150.00
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


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