Includes appendices, bibliographical references and index.

Introduction -- Classifying medical devices -- The design process -- Implementing design procedures -- Developing your product design specification -- Generating ideas and concepts -- Enhancing quality in design -- Design realisation/detailed design -- Risk management, risk analysis and ISO 14971 -- Evaluation (validation and verification) -- Manufacturing supply chain -- Labeling and instructions for use -- Post market surveillance -- Protecting your IP -- Obtaining regulatory approval to market.

This text 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.