What appears in the "Identification of characteristics related to safety" section of the Risk Management File?

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In Ketryx standard defaults, this section of the Risk Management File will be populated with all design inputs and outputs (RQ, SW, HW) that have the Context field set to Safety.


This section exists to help you comply with ISO 14971 5.3, which states "For the particular medical device being considered, the manufacturer shall identify and document those qualitative and quantitative characteristics that could affect the safety of the medical device. Where appropriate, the manufacturer shall define limits of those characteristics. This documentation shall be maintained in the risk management file."
This gives you the ability to write these qualitative and quantitative characteristics as design inputs or outputs, provide detail and define limits in the text of the item, and connect tests to these items.


It is important to note that items will only be included in this section of the Risk Management File when they are included in the given version.

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