ISBN 978-1-4822-4838-8

This book provides a clear presentation of the global regulatory requirements and challenges in evaluating the biocompatibility and clinical safety of the materials used in producing medical devices, and the devices themselves. Starting with material characterization and selection, considerations of concerns arising from packaging and contact with production machinery, and extensive coverage of combination products the book also provides the latest approaches to isolating, quantitating, identifying and assessing the risk arising from chemical entities released from market ready devices.