Medical Device Hazard Analysis (ISO 14971)

Overview:
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:
Engineer
Engineering Manager
Regulatory Personnel
QA

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
Email: [email protected]

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WHEN AND WHERE

02 October 2018
United States of America

ORGANIZER

Netzealous LLC DBA - Compliance4All

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Added 5 years ago by Compliance4All on Education