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Medical Device Design: Innovation from Concept to Market, Third Edition, provides the bridge between engineering design and medical device development. It clearly explains the process of medical device development - from very early stages of conceptualization to commercialization on the global market. It addresses medical devices' regulatory (FDA and EU) requirements, shows the essential methodologies medical designers must understand to ensure their products meet requirements, and brings together proven design protocols, enabling engineers and medical device manufacturers to rapidly bring new products to the marketplace.Medical Device Design: Innovation from Concept to Market, Third Edition, is suitable for professional engineers, both new and experienced, as well students taking a course in medical device design.
- Provides a reference to standards and regulations that have been updated, including ISO 13485:2016, FDA regulations and the European Medical Device Regulation
- Step by Step approach helps to convey the 'flow' of a design project
- Combines real world experience with academic knowledge
- Presents realistic and practical methodologies derived from cutting edge design research.
- Interdisciplinary approach that is applicable to a range of medical devices design disciplines, from microelectronics to mechanical engineering.
- Extensive case studies show all aspects of medical device design in practice