Assessment to ensure a medical device will not cause unacceptable harm when implanted in or applied to a patient is a crucial step in the development process. This evaluation includes a series of laboratory tests and, when needed, animal studies designed to predict how the body will respond to the device. For example, a new hip implant undergoes rigorous analysis to determine if its materials will cause inflammation, allergic reactions, or other adverse effects within the body.
Thorough evaluation is paramount for patient safety and the overall success of innovative medical technologies. These evaluations safeguard against potential complications, improve device performance, and contribute to regulatory compliance. Historically, inadequate examination led to serious health issues, highlighting the critical need for robust and standardized methods to protect individuals receiving medical treatments.