Understanding Sequence of Events and Hazardous Situations
Автор: Let's Talk Risk!
Загружено: 2022-10-26
Просмотров: 1066
Confused about sequence of events and hazardous situations? You are not alone!
These are fundamental concepts in risk management of medical devices. However, in practice, it becomes very hard to clearly define all potential sequence of events and hazardous situations.
How far should you develop the description of a sequence of events? How many hazardous situations should you identify for each sequence of events? Should you extend your analysis all the way to death even when there is practically no link to the medical device, but the surgical procedure may itself be risky?
These are important questions, but it is not easy to find good answers. In this video, I explain these concepts in detail and clarify the requirements of ISO 14971:2019. You will also find best practices to use these concepts in estimating the risk of harm.
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