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The Risk Management Report contains the output and summary of risk management activities for the risk management file. The procedures used for the risk assessment and risk management file in general are captured in the Risk Management Plan and the risk management report is a review that the risk management plan has been executed successfully.
Additional information related to the implementation of risk controls and processes related to product development and risk procedures are found in the SOP Integrated Software Development.
The risk analysis is captured in the Risk Assessment and was conducted according to the Risk Management Plan.
The following table provides information regarding the data included in the risk analysis performed as part of the risk assessment.
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Risks were reduced as far as possible (AFAP). If a risk was classified as "unacceptable" based on the Risk Matrix, risk control measures were implemented.
The following categories of risk control measures were implemented in priority as listed below:
The table below provides data regarding risk control measures implemented.
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The benefit-risk assessment of the product is described in the clinical evaluation and takes into account the overall residual risk of the product evaluated through the risk assessment process. All unacceptable risks, if any, will be identified and compared against the benefits of the product in the clinical evaluation report to determine the overall benefit-risk ratio.
There has been established a process for the identification and analyzation of potential risks during production and post-production for the medical device. These processes are captured in the following documents:
Risks identified during this processes can serve as inputs to the risk management file and may require review of the risk assessment following incorporation of the new risks.
