Medical Device Risk Identification, Analysis and Control - ISO 14971

Device Risk Identification, Analysis and Control Template - EN ISO 14971:2019+A11:2021

As part of the requirements for placing a medical device or IVD on the market, the manufacturer needs to demonstrate that risk management of the device has taken place. There is a risk management standard for medical devices named EN ISO 14971. This standard states that the manufacturer needs to document the known and foreseeable risks associated with the device. This is done by identifying the hazards posed by the device, analysing the potential risk level, controlling and mitigating the risks. This template provides the tools necessary to log the risks associated with the device, calculate the risk levels, and control the risks.

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