Medical Device Design and Regulation

  1. Pre-Clinical Testing
    1. Benchtop Testing
      1. Mechanical Testing
        1. Fatigue Testing
          1. Tensile Testing
            1. Torsion Testing
              1. Compression Testing
              2. Electrical Safety Testing
                1. Insulation and Leakage Testing
                  1. Electromagnetic Compatibility
                  2. Software Verification and Validation
                    1. Unit Testing
                      1. Integration Testing
                        1. System Testing
                      2. Animal Studies
                        1. Good Laboratory Practice
                          1. GLP Principles
                            1. Compliance and Documentation
                            2. Study Design and Model Selection
                              1. Species Selection
                                1. Study Endpoints
                                2. Ethical Considerations
                                  1. Institutional Animal Care and Use Committee
                                    1. 3Rs Principle
                                      1. Replacement
                                        1. Reduction
                                          1. Refinement

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                                    8. Materials and Biocompatibility

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                                    10. Clinical Evaluation and Trials