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Full Description
This book highlights the responsibility of medical device designers and engineers to eliminate sites of failure and to test devices to demonstrate their ultimate safety and efficacy. It also evaluates biomaterials and their properties as related to the design and reliability of medical devices. The principles that are described are readily applicable to the biomaterial scaffolds used for generating tissue-engineered constructs.
Contents
Overview and Introduction: Unique Aspects of Biomaterials in the Safety and Efficacy of Medical Implant Devices; M.N. Helmus. Standards and Guidelines for Biocompatibility for Medical Devices; S. Northup. Medical Device Regulation; B. Sall. Medical Device Testing; S. Northup. Failure Analysis: Learning for the Future from the Past; M.N. Helmus. Biomaterials Testing Issues in Small Business; R. Snyder. Tissue Engineering Constructs and Commercialization; K. Brockbank. Testing of Bioactive Biomaterial: A Case Study; K. Tweden.