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This book provides the bridge between engineering design and medical devices development. There is no single text that addresses the plethora of design issues a medical devices designer meets when developing new products or improving older ones. It addresses medical devices regulatory (FDA and EU) requirements: some of the most stringent engineering requirements globally. Engineers failing to meet these requirements can cause serious harm to users as well as their products' commercial prospects. This Handbook shows the essential methodologies medical designers must understand to ensure their products meet requirements. It brings together proven design protocols and puts them in an explicit medical context, based on the authors' years of experience in academia (R&D phase) and industrial (commercialization phase) experience. This design methodology enables engineers and medical device manufacturers to bring new products to the market place rapidly. Covers US FDA and EU MDD standards, enabling a truly international approach Present a proven design methodology that enables medical engineers and medical device manufacturers to bring new products to the market place efficiently Experienced US and UK based authors with a long track record of delivering successful products to market, helps to supported the text throughout with real-world case studies and design examples