Risk Management file (RMF)

What is a risk management file (RMF)?

A Risk Management File (RMF) is a comprehensive set of documents that systematically identifies, assesses, and mitigates risks associated with your medical device as mandated by relevant standards and regulations, particularly ISO 14971:2019 (Medical Devices – Application of Risk Management to Medical Devices). The RMF ensures that risks associated with the medical device are identified, evaluated, controlled, and monitored throughout its lifecycle. The key documents under the RMF typically include:

The risk management plan (RMP)
The risk analysis and control (RAC) document
The risk management report (RMR)

More documents may be included in your RMF, depending on what is written in your SOP for risk management.

AML Christensen’s service

At AML Christensen, we can help you create and maintain your RMF in accordance with ISO 14971:2019 and ISO/TR 24971:2020. The RMF must be maintained during the complete life cycle of your medical device to accommodate new information and ensure continued compliance with regulatory standards in accordance with what is defined in your SOP for risk management. In cases of design changes to the device, a review of the risk management documentation is required.

The creation and maintenance of a comprehensive RMF may involve a cross-functional collaboration with your engineering, quality assurance, regulatory affairs, and clinical teams to ensure that all aspects of risk management are thoroughly addressed.

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Risk Management file (RMF)

What is a risk management file (RMF)?

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