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

Event Fee: One Dial-in One Attendee Price: US $150.00

Contact Detail:

Compliance4All DBA NetZealous,

Phone: +1-800-447-9407

Email: support@compliance4All.com

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.