Medical Device Safety

"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

• PREFACEACKNOWLEDGMENTSFOREWORDINTRODUCTIONTHE TRANSFORMATION IN THE EUROPEAN COMMUNITYTHE CURRENT SITUATION-THE EC MEDICAL DEVICE DIRECTIVETHE CURRENT SITUATION-REGULATIONS IN USA AND JAPANA Comparison with the Medical Devices DirectiveTHE CURRENT SITUATION-REGULATORY DEVELOPMENTS IN OTHER COUNTRIESTHE PLACE OF QUALITY SYSTEMSTHE USE OF PRODUCT STANDARDSTHE QUESTION OF EFFECTIVENESSPOST-MARKET CONTROLSPROPOSALS AND PROSPECTS FOR A GLOBAL REGULATORY SYSTEM FOR MEDICAL DEVICESOVERVIEW AND LOOK TO THE FUTUREAPPENDICESREFERENCESBIBLIOGRAPHY