Medical Device Safety: The Regulation of Medical Devices for Public Health and Safety examines the prospects for achieving global harmonization in medical device regulation and describes a possible future global system. Unresolved difficulties are discussed while solutions are proposed. An essential book for all those involved in health physics, engineering,...more

Since the publication of the bestselling first edition, a number of important methodological and computational advances have emerged, accompanied by major leaps in statistical computing. Modelling Binary Data, Second Edition continues to provide a comprehensive, practical guide to the statistical methods, but is now fully updated to reflect recent developments...more

Design Controls for the Medical Device Industry provides real-world examples, strategies, and templates for the implementation of effective design control programs that meet current ISO 9000 and FDA QSR standards and regulations. It also offers product development models for the production of safe, durable, and cost-efficient medical devices and systems....more

As a rule, when a distinguished scientist says he's come up with a fourth law of thermodynamics, he's wrong. Stuart Kauffman may be the exception.

The three laws of thermodynamics have been summarized as: You can't win, You...more

This reference examines laboratory techniques and FDA and industry perspectives on medical, food service, and consumer product applications of antimicrobials. It offers methods to conduct investigations of effectiveness that simulate use of consumer, food, and medical antimicrobials in real-world conditions and environments, validate neutralizing systems, develop reliable and functional antimicrobial...more