Moderate Level of Concern

Medical device
"The Level of Concern is moderate if the operation of the software associated with device function directly affects the patient, operator, and/or bystander so that failures or latent design flaws could result in non-serious injury to the patient, operator, and/or bystander, or if it indirectly affects the patient, operator, and/or bystander (e.g., through the action of the care provider) where incorrect or delayed information could result in non-serious injury of the patient, operator, and/or bystander."