Integrated Safety and Risk Assessment for Medical Devices and Combination Products

• Main Author: Gad, Shayne C. (Author, http://id.loc.gov/vocabulary/relators/aut)
• Corporate Author: SpringerLink (Online service)
• Format: Electronic eBook
• Language: English
• Published: Cham : Springer International Publishing : Imprint: Springer, 2019.
• Edition: 1st ed. 2019.
• Subjects: Pharmacology.; Pharmacology/Toxicology.

While the safety assessment ("biocompatibility") of medical devices has been focused on issues of local tissue tolerance (irritation, sensitization, cytotoxicity) and selected quantal effects (genotoxicity and acute lethality) since first being regulated in the late 1950s, this has changed...

Table of Contents:

• 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.