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Medical Device Risk Management Plan - ISO 14971

Medical Device Risk Management Plan - ISO 14971

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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.

If you would like further information on our wide range of templates or have any suggestions for improvement that require support in addition to our templates in the form of other Medical Device Quality Assurance or Regulatory Affairs services, contact us at qmsregs@patientguard.com.

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