Design of biomedical devices and systems / Paul H. King, Richard C. Fries, Arthur T. Johnson.

Includes bibliographical references and index.

Introduction to biomedical engineering design -- Fundamental design tools -- Design team management, reporting, and documentation -- Product definition -- Product documentation -- Product development -- Hardware development methods and tools -- Software development methods and tools -- Human factors -- Industrial design -- Biomaterials and material testing -- Risk analysis devices and processes -- Testing -- Analysis of test data -- Product liability and accident investigations -- The FDA and devices -- FDA history and relevant non-device regulations -- Biological engineering design -- International regulations and standards -- Intellectual property : patents, copyrights, trade secrets and licensing -- Manufacturing and quality control -- Miscellaneous issues -- Professional issues -- Concept to product?.