Springer Biomaterials, Medical Devices & Tissue Engineering - Springer

This comprehensive guide explores the integrated approach to biomaterials, medical devices, and tissue engineering, covering the critical processes from material selection through regulatory approval. The book details how materials are evaluated for biocompatibility using ASTM standard procedures, with prototypes tested for sterility and freedom from pyrogens before animal or human trials. Readers will learn how medical devices are classified as Class I, II, or III based on invasiveness levels, and understand the distinct FDA pathways each class requires - from simple notification for Class I devices to pre-marketing approval or equivalence demonstration for Class II and III devices. Essential for biomedical engineers, healthcare practitioners, and professionals developing innovative medical technologies and tissue engineering solutions.