Fries R.C., King P.H. Design of Biomedical Devices and Systems

Hoboken: CRC Press, 2008. — 424 p.Introduction to biomedical engineering design
Fundamental design tools
Design team management, reporting, and documentation
Product definition
Product documentation
Product development
Hardware development methods and tools
Software development methods and tools
Human factors
Industrial design
Biomaterials and material testing
Safety engineering : devices and processes
Testing
Analysis of test data
Reliability and liability
Food and Drug Administration
Regulation and standards
Licensing, patents, copyrights, and trade secrets
Manufacturing and quality control
Miscellaneous issues
Product issues
Professional issues
Design case studies
Future design issues.