Springer - Biomaterials, Medical Devices and Tissue Engineering

Explore the fundamental principles of medical technology with this comprehensive text from Springer. This resource covers the essential processes involved in developing medical devices, from initial material selection to meeting biocompatibility requirements. Readers gain knowledge on building and testing prototypes using ASTM standard procedures to ensure safety and effectiveness. Understanding the regulatory landscape is a major part of this text. It explains the critical validation steps for sterility and freedom from pyrogens required before any testing on animals or humans can occur. The book also provides a clear breakdown of medical device classifications. You will learn how Class I, II, and III devices are categorized based on invasiveness and the specific FDA pathways required for marketing, including notification processes and pre-marketing approval requirements.