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The danger of division - Part 3 feature image

Design risk assessment, process risk assessment, and use risk assessment for medical devices – the danger of division (Part 3)

As the final part of this series, this article focuses on categorising risks based on the different life-cycle phases of a medical device in order to efficiently address them to avoid harm. Not all medical device manufacturers segment their documentation into three distinct documents but risk association with life-cycle phases is common in the industry.

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