Medical Device Design
Innovation from concept to market
By- Peter Ogrodnik, Professor of Engineering Design at Staffordshire University (UK) and co-founder of Intelligent Orthopaedics Ltd.
Hardbound, 376 Pages
Published: November 2012
Imprint: Academic Press
ISBN: 978-0-12-391942-7
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
