Biomaterials and Tissue Engineering

  1. Regulatory and Clinical Translation
    1. Regulatory Framework
      1. FDA Regulations
        1. Device Classification
          1. Premarket Pathways
            1. 510(k) Clearance
              1. Premarket Approval
                1. De Novo Classification
                2. Quality System Regulation
                3. International Regulations
                  1. CE Marking
                    1. ISO Standards
                      1. ICH Guidelines
                    2. Preclinical Development
                      1. Study Design
                        1. Animal Models
                          1. Small Animal Models
                            1. Large Animal Models
                              1. Model Selection Criteria
                              2. Good Laboratory Practices
                                1. Endpoints and Assessments
                                2. Clinical Trials
                                  1. Phase I Trials
                                    1. Phase II Trials
                                      1. Phase III Trials
                                        1. Good Clinical Practices
                                          1. Data Management
                                          2. Manufacturing Considerations
                                            1. Good Manufacturing Practices
                                              1. Quality Control
                                                1. Sterilization
                                                  1. Packaging and Labeling
                                                    1. Supply Chain Management
                                                    2. Post-Market Surveillance
                                                      1. Adverse Event Reporting
                                                        1. Post-Market Studies
                                                          1. Risk Management
                                                          2. Ethical Considerations
                                                            1. Research Ethics
                                                              1. Patient Safety
                                                                1. Risk-Benefit Analysis
                                                                2. Intellectual Property
                                                                  1. Patents
                                                                    1. Trade Secrets
                                                                      1. Freedom to Operate
                                                                        1. Licensing

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                                                                      14. Medical Device Applications

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                                                                      16. Emerging Technologies and Future Directions