What is a Risk Management File?

ISO 14971:2019 defines the Risk Management file as a “set of records and other documents that are produced by risk management”. In practice, the risk management file must contain, or have reference to, the following documents: (4.2, Note 3) The policy for establishing criteria for risk acceptability. (4.4) The Risk Management Plan. (4.5) Traceability for […]

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How to Customize your Product Risk Matrix in Atlassian Jira

With SoftComply Risk Manager , you will work with a fully customizable Risk Matrix to identify, evaluate, mitigate and verify your product risks. SoftComply Risk Manager automatically generates Risk Matrices and Risk Reports! SoftComply Risk Manager is an add-on for Atlassian Jira – try it out for free for a month from Atlassian Marketplace. Short […]

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