C4A – Medical Device Hazard analysis following ISO 14971

June 9, 2021 @ 9:00 am – 10:00 am


By Edwin Waldbusser


In this webinar we will explain in detail the process of conducting a hazard analysis. The confusing terms “hazard”, hazardous situation”, “harm”, “causative event”, “ALARP”, “risk index”, “benefit/ risk ratio”, and “residual risk” will be explained.

We will go step by step through a template for risk analysis so that the process is clear. Examples of hazards and hazardous situations will be discussed. How to deal with residual risk will be discussed.

We will explain how to integrate Human Factors studies into the Hazard Analysis and how to integrate Hazard Analysis into the design program. Risk level can determine the extent of CAPA investigations, validations effort, etc.

Application of ISO 14971 principles to software risk management will be explained.

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