Axonics Entrance Practice Test

Hazard analysis identifies what could cause harm. It’s about spotting potential hazards and hazardous situations related to the device, its use, labeling, and foreseeable misuse—without judging how likely or how severe those harms are yet. Risk assessment uses that list to judge how serious and how likely each hazard is. It evaluates the severity of the harm if it occurs and the probability or frequency of its occurrence, often considering exposure and detectability. This step yields a risk level to guide whether controls are needed and how effective those controls are, including assessing residual risk after applying safety measures. For example, in a medical device, hazard analysis might flag risks like electrical overstimulation, insulation failure, lead fracture, or infection. The risk assessment would then assign levels for how severe the harm could be and how likely each hazard is, helping determine appropriate design changes, labeling, or protective measures to bring overall risk to an acceptable level.