Medical Device Design, 1st Edition

Key Features

• The medical device market is a multi-billion dollar industry. Every engineered product for this sector, from scalpelsstents to complex medical equipment, must be designed and developed to approved procedures and standards. This book shows how.
• Covers US, and EU and ISO standards, enabling a truly international approach, providing a guide to the international standards that practicing engineers require to understand.
• Written by an experienced medical device engineers and entrepreneurs with products in the from the US and UK and with real world experience of developing and commercializing medical products.

Medical Device Design, 1st Edition

1. Introduction
2. Classifying medical devices
3. The design process
4. Implementing design procedures
5. Developing your product design specification
6. Generating ideas and concepts 
7. Quality in design
8. Design realization/Detailed design
9. Evaluation (validation and verification)
10. Manufacturing supply chain
11. Labeling and instructions for use
12. Postmarket surveilance
13. Protecting your IP
14. Obtaining regulatory approval to market