Medical Device Design and Regulation

  1. The Medical Device Lifecycle
    1. Concept and Ideation
      1. Identifying Unmet Clinical Needs
        1. Brainstorming and Innovation Techniques
          1. Feasibility Assessment
            1. Intellectual Property Considerations
            2. Design and Development
              1. Prototyping
                1. Iterative Design
                  1. Design Documentation
                  2. Pre-clinical and Clinical Evaluation
                    1. Pre-clinical Testing Strategies
                      1. Clinical Study Planning
                        1. Regulatory Requirements for Evaluation
                        2. Regulatory Submission and Approval
                          1. Preparation of Submission Dossiers
                            1. Communication with Regulatory Authorities
                              1. Review and Response Process
                              2. Manufacturing and Commercialization
                                1. Scale-up and Technology Transfer
                                  1. Supply Chain Management
                                    1. Marketing and Sales Strategies
                                    2. Post-Market Surveillance
                                      1. Monitoring Device Performance
                                        1. Adverse Event Reporting
                                          1. Product Improvements and Updates

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                                        1. Introduction to Medical Device Engineering

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                                        3. Regulatory Foundations