1. Introduction – History and Where We are Headed
2. Regulatory Guidance
3. Sample Preparation and Biocompatibility Testing
4. Testing for Leachables and Extractables
5. Where the Data is – And What is It?
6. Bridging Issues of Route
7. Risk Assessments for Medical Devices
8. (Q)SAR
9. Histopathology in Medical Device Studies
10. Assessment of Nanomaterial Devices
11. Integrated Safety Assessments for Devices
12. Toxicity of Common Extractables and Leachables.