Medical Device Design and Regulation

  1. Clinical Evaluation and Trials
    1. Clinical Evaluation Report
      1. Literature Review
        1. Clinical Data Analysis
          1. Equivalence Assessment
          2. Investigational Device Exemption
            1. Application Process
              1. Monitoring and Reporting Requirements
              2. Clinical Trial Design and Phases
                1. Feasibility and Pilot Studies
                  1. Pivotal Studies
                    1. Post-Market Clinical Follow-up
                    2. Good Clinical Practice
                      1. Principles of GCP
                        1. Compliance and Monitoring
                        2. Institutional Review Board
                          1. Role and Responsibilities
                            1. Review Process
                            2. Data Analysis and Statistical Methods
                              1. Study Endpoints
                                1. Statistical Power and Sample Size
                                  1. Data Management and Integrity

                                Previous

                                9. Pre-Clinical Testing

                                Go to top

                                Next

                                11. Regulatory Submission Pathways