Definition
Medical device
"The Level of Concern is major if operation of the software associated with device function directly affects the patient, operator, and/or bystander so that failures or latent flaws could result in death or 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 care provider) such that incorrect or delayed information could result in death or serious injury to the patient, operator, and/or bystander."[1]