Risk management report is used to document a summary of risk management activities.
It is one of the most important documents in your risk management file because it provides an evidence of the risk management review per the requirements of ISO 14971.
More importantly, the risk management report is reviewed by outside parties such as regulators and notified body auditors. It must provide a clear, conclusive evidence of the acceptability of the overall residual risk in the context of the benefits of the intended use.
This video offers tips for writing a good risk management report.
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Негізгі бет Ғылым және технология Attributes of a good risk management report
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