"This book provides a good overview of the existing regulations within the principle areas without becoming bogged down in the details of those regulations … it is a good compilation of the existing state of regulatory affairs concerning medical devices in general. The author did an excellent job in comparing and contrasting the various regulations and regulatory rationales." -James G. Yusko, Health Physics "This comprehensive, lucid treatise is recommended for all collections that deal with medical devices, standards, or regulations." -E-STREAMS, Vol. 5, No. 4 "Unlike the various papers which have been published previously, this book gives a fair and unbiased comparison of the strengths and weaknesses of various approaches. The overall result is an informed text written with a firm conviction that things are heading in the right direction and a clear vision of what that direction is … This book is an essential read for anyone involved with the design, marketing, or regulatory affairs aspects of medical devices. It should be in the library of all medical device regulators and manufacturers (including university and hospital clinical engineering departments)." -W. J. O'Dowd, Physics in Medicine & Biology