Main description:

This book provides the bridge between engineering design and medical device 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 author's years of academia (R&D phase) and industrial (commercialization phase) experience. This design methodology enables engineers and medical device manufacturers to bring new products to the marketplace rapidly.

Contents:

Introduction
Classifying medical devices
The design process
Implementing design procedures
Developing your product design specification
Generating ideas and concepts
Quality in design
Design realization/Detailed design
Evaluation (validation and verification)
Manufacturing supply chain
Labeling and instructions for use
Postmarket surveilance
Protecting your IP
Obtaining regulatory approval to market