What does "risk assessment" primarily involve when evaluating medical devices?

The process of risk assessment in the context of evaluating medical devices is primarily focused on identifying potential hazards associated with the device and analyzing the associated risks of its use. This involves a systematic examination of what could go wrong when a device is used and who may be affected by these risks. Key components of risk assessment include understanding possible hazards (e.g., mechanical failure, toxicity of materials, etc.), the likelihood of occurrence, potential severity of harm, and existing controls or risk mitigations.

By systematically identifying these aspects, manufacturers and regulatory bodies can ensure that medical devices are safe for use and meet applicable regulatory standards. This proactive approach not only protects patients and users from potential harm but also supports compliance with regulatory requirements. Furthermore, the results of this risk assessment process inform product design, labeling, and post-market surveillance activities to further manage risks throughout the product lifecycle.

Other options focus on irrelevant aspects of medical device management or marketing that do not directly relate to the safety and efficacy analysis required during risk assessment.