Risk Module

REQUIRES 'RISK' MODULE

The risk module allows you to define risks and link them to mitigations. It is possible to customize the risk formula to take parameters into account like probability, severity or detectability and multiply or add these to calculate a risk before mitigation value. The module allows to choose mitigations such as requirements and/or specifications which are used as mitigations to reduce the risk factors specified as input. It is also possible to add checkboxes to indicate that the risk level is mitigated as far as possible and the remaining risks do not outweigh the benefits of the device to support documentation according to EN ISO 14971:2019. 

The risks can now be defined at the risk field level within a category.

When that is done, the risk definition there overwrites the default (project) risk settings.

This allows to create more than one type of risks in a single project.


See Risk Management for configuration options.