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Risk Management

The purpose of this section is to answer questions related to the usage and operations of the Ketryx Lifecycle Management system pertaining to Risk items that act in accordance with ISO 14971 and IEC 62304.

  • I only have one p value - can I remove the other field from the risk screen?
  • Can I use the Jira External Systems Importer to import my risk items, along with their risk matrices?
  • How can I filter and manage risks of different types?
  • Why is the Risk edit screen showing errors when I try to save?
  • What appears in the "Identification of characteristics related to safety" section of the Risk Management File?
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