Medical Device Design and Regulation

  1. Specialized Topics in Medical Device Design
    1. Human Factors Engineering and Usability
      1. User Interface Design
        1. Formative Usability Testing
          1. Summative Usability Testing
            1. Human Factors Validation
            2. Software as a Medical Device
              1. Definition and Scope
                1. Software Development Lifecycle
                  1. Software Planning
                    1. Software Requirements
                      1. Software Design and Implementation
                        1. Software Verification and Validation
                          1. Software Maintenance
                          2. Cybersecurity for Medical Devices
                            1. Threat Assessment
                              1. Security Controls
                                1. Regulatory Guidance
                                2. Artificial Intelligence and Machine Learning in Medical Devices
                                  1. Algorithm Development
                                    1. Validation and Transparency
                                      1. Regulatory Considerations
                                    2. Combination Products
                                      1. Device-Drug Combinations
                                        1. Device-Biologic Combinations
                                          1. Regulatory Pathways for Combination Products
                                          2. In Vitro Diagnostic Devices
                                            1. Definition and Types
                                              1. Regulatory Requirements
                                                1. Performance Evaluation
                                                2. Reprocessing and Reusability of Medical Devices
                                                  1. Cleaning and Disinfection
                                                    1. Sterilization Validation
                                                      1. Labeling for Reusable Devices
                                                        1. Regulatory Considerations for Reprocessed Devices

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                                                      13. Post-Market Surveillance and Activities

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                                                      1. Introduction to Medical Device Engineering