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.