Medical Device Risk Management Plan - ISO 14971

Device Risk Management Plan Template - BS EN ISO 14971:2019+A11:2021

As part of the medical device risk management activities, a medical device must demonstrate compliance with risk management standard EN ISO 14971. The standard states that there must be a risk management plan in place, which details the actions required to perform risk management activities throughout the life time of the medical device. This template meets the requirements of a risk management plan as per EN ISO 14971.

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