This ebook gives the bridge between engineering design and medical device development. There is no such thing as a single text that addresses the plethora of design issues a medical gadgets designer meets when growing new merchandise or bettering older ones. It addresses medical devices' regulatory (FDA and EU) requirements--some of the most stringent engineering requirements globally. Engineers failing to fulfill these requirements may cause severe harm to customers in addition to their merchandise' commercial prospects. This Handbook exhibits the important methodologies medical designers should understand to make sure their merchandise meet requirements. It brings collectively confirmed design protocols and puts them in an express medical context based on the writer's years of academia (R&D part) and industrial (commercialization section) experience. This design methodology enables engineers and medical system producers to convey new merchandise to the marketplace rapidly.
The medical gadget market is a multi-billion greenback industry. Each engineered product for this sector, from scalpelsstents to advanced medical tools, have to be designed and developed to authorized procedures and standards. This ebook exhibits how.
Covers US, and EU and ISO standards, enabling a truly international method, offering a information to the international requirements that training engineers require to understand.
Written by an experienced medical machine engineers and entrepreneurs with merchandise in the from the US and UK and with actual world experience of developing and commercializing medical products.
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