Hazard Analysis Following ISO 14971

Conducting a Design Control Program into which risk management is inbuilt, should become part of a product development. This is an expectation of the FDA. It has laid down the ISO 14971 as a guide to this program, which means that it accepts any product development program that meets the requirements set out in this standard. Hazard Analysis is one of the core techniques described in the ISO 14971.

Why the ISO 14971 is considered the most powerful among the risk management techniques is that it considers risks in both normal operation as well as fault conditions. This is where it differs from the FMEA and FTA, which consider risks in only fault conditions, making them better reliability tools than product safety tools.

Clearing the confusions surrounding ISO 14971

There are a few confusing terms in the ISO 14971 standard, though. These include "hazard", "hazardous situation", "harm", "causative event", "ALARP", "risk index", and "residual risk" among others.

A webinar from Traininng.com, a leading provider of professional training for all the areas of regulatory compliance, will offer clarity on these confusing terms. At this webinar, Edwin Waldbusser, who has been consulting in the US and internationally in the areas of design control, risk analysis and software validation for the past eight years, will be the speaker.

Please visit http://bit.ly/2J1YtJx to enroll for this webinar.

• The purpose of this webinar is to offer a detailed explanation of the process of conducting a hazard analysis. Edwin will go step by step through a template for hazard analysis to make the process clear. He will introduce many new concepts and provide examples so that the participants get a proper and thorough understanding of the process.

Through a discussion of the examples of hazards and hazardous situations, Edwin will show how to deal with residual risk. He will take participants step-by-step through a typical hazard analysis. Another vital learning that the speaker will impart at this session is on how to integrate Human Factors studies into the Hazard Analysis and how to integrate Hazard Analysis into the design program.

In this session, which is of very high value to those who have to implement ISO 14971, such as Engineer, Engineering Manager, Regulatory Personnel, and QA; Edwin will cover the following areas:

• 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.
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About the speaker: A Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness network; Edwin Waldbusser is a consultant who has retired from industry after 20 years in management of development of medical devices. He holds five patents.

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