Medical Device Hazard Analysis Following ISO 14971 - 2017

PUBLISHED 1 month ago BY Compliance4all ON SOCIAL SCIENCES 46 Views
Overview:
The US FDA expects that as part of a product development Design Control

Program risk management will be conducted. FDA recommends using ISO

14971 as a guide and has accepted it as a recognized standard.

Why should you Attend:
FDA expects that as part of a product development program risk management

will be conducted. FDA recommends using ISO 14971 as a guide and has

accepted it as a recognized standard.

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.

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]