Implant and device manufacturers are increasingly having to face the challenge of proving that their implants or devices are safe/biocompatible and perform as promised. It is also vital that manufacturers can safely and effectively predict the biocompatibility of their devices before they are implanted. The international team of contributors and editor describe and explain the factors that influence the biocompatibility of materials and medical devices. Introductory chapters provide an introduction to biocompatibility, look at the evaluation and characterization of biocompatibility in medical devices and review testing and interpretation of medical device performance. The conclusion explains the histopathological principles for biocompatibility and performance studies.