Design of biomedical devices and systems

Content: Introduction to Biomedical Engineering Design. Fundamental Idea Generation Techniques. Process Analysis Tools., and Evaluation Methods. 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. Risk Analysis--Devices and Processes. Testing. Analysis of Test Data. Product Liability and Accident Investigations. The FDA and Devices. FDA History and Relevant Non-Device Regulations. Biological Engineering Designs. International Regulations and Standards. Intellectual Property: Patents, Copyrights, Trade Secrets, and Licensing. Manufacturing and Quality Control. Miscellaneous Issues. Professional Issues. Concept to Product? Appendix 1:  2Table. Appendix 2: Percent Rank Tables. Appendix 3: 40 Inventive Principles, Engineering Parameters, and Conflict Matrix. Appendix 4: Glossary.