biological evaluation

Biological evaluation is a process used to assess how a medical device interacts with the human body. It involves testing to ensure the device is safe and biocompatible, meaning it doesn't cause harm or adverse reactions like allergies or toxicity. This includes examining material properties, performing laboratory tests, and sometimes in vivo studies. The goal is to identify any potential biological risks before the device is approved for widespread use, ensuring it performs safely within the body during its intended lifespan.