Shayne Cox Gad, PhD, DABT, Gad Consulting Services, Raleigh, North Carolina, USASamantha Gad-McDonald, B.S.ENGR, Gad Consulting Services, Raleigh, North Carolina, USA

• Safety Evaluation of Medical Devices. Regulatory Aspects and Strategy in Medical Device and Biomaterials Safety Evaluation. Road Map to Test Selections. Materials in Medical Device Design. What to Test: Sampling and Sample Preparation. Cytotoxicity Testing. Hemocompatibility (ISO 10993-4). Local Tissue Tolerance. Immunotoxicology (ISO 10993-20). Implantation Biology and Studies. Acute Systemic Toxicity Testing and Device Safety Evaluation. Genotoxicity. Subchronic and Chronic Toxicity and Reproductive and Developmental Toxicity. Carcinogenicity. Degradation Products and Impurities Processes in Medical Devices. Special Case Devices. Combination Products. Clinical Studies for Medical Devices. Leachables and Extractables from Medical Devices. Toxicokinetics in Biomaterial and Device Safety Evaluation. Special Studies. Case Histories and Problem Resolution. Appendix A: Selected Regulatory and Toxicological Acronyms. Appendix B: Contract Testing Laboratories. Appendix C: Notable Regulatory Internet Addresses. Appendix D: Non-U.S. Medical Device Regulators.

Shayne Cox Gad, PhD, DABT, Gad Consulting Services, Raleigh, North Carolina, USASamantha Gad-McDonald, B.S.ENGR, Gad Consulting Services, Raleigh, North Carolina, USA

• Safety Evaluation of Medical Devices. Regulatory Aspects and Strategy in Medical Device and Biomaterials Safety Evaluation. Road Map to Test Selections. Materials in Medical Device Design. What to Test: Sampling and Sample Preparation. Cytotoxicity Testing. Hemocompatibility (ISO 10993-4). Local Tissue Tolerance. Immunotoxicology (ISO 10993-20). Implantation Biology and Studies. Acute Systemic Toxicity Testing and Device Safety Evaluation. Genotoxicity. Subchronic and Chronic Toxicity and Reproductive and Developmental Toxicity. Carcinogenicity. Degradation Products and Impurities Processes in Medical Devices. Special Case Devices. Combination Products. Clinical Studies for Medical Devices. Leachables and Extractables from Medical Devices. Toxicokinetics in Biomaterial and Device Safety Evaluation. Special Studies. Case Histories and Problem Resolution. Appendix A: Selected Regulatory and Toxicological Acronyms. Appendix B: Contract Testing Laboratories. Appendix C: Notable Regulatory Internet Addresses. Appendix D: Non-U.S. Medical Device Regulators.

Shayne Cox Gad, PhD, DABT, Gad Consulting Services, Raleigh, North Carolina, USASamantha Gad-McDonald, B.S.ENGR, Gad Consulting Services, Raleigh, North Carolina, USA

• Safety Evaluation of Medical Devices. Regulatory Aspects and Strategy in Medical Device and Biomaterials Safety Evaluation. Road Map to Test Selections. Materials in Medical Device Design. What to Test: Sampling and Sample Preparation. Cytotoxicity Testing. Hemocompatibility (ISO 10993-4). Local Tissue Tolerance. Immunotoxicology (ISO 10993-20). Implantation Biology and Studies. Acute Systemic Toxicity Testing and Device Safety Evaluation. Genotoxicity. Subchronic and Chronic Toxicity and Reproductive and Developmental Toxicity. Carcinogenicity. Degradation Products and Impurities Processes in Medical Devices. Special Case Devices. Combination Products. Clinical Studies for Medical Devices. Leachables and Extractables from Medical Devices. Toxicokinetics in Biomaterial and Device Safety Evaluation. Special Studies. Case Histories and Problem Resolution. Appendix A: Selected Regulatory and Toxicological Acronyms. Appendix B: Contract Testing Laboratories. Appendix C: Notable Regulatory Internet Addresses. Appendix D: Non-U.S. Medical Device Regulators.