Medical Device Design and Regulation

  1. The Design and Development Process
    1. Design Models and Methodologies
      1. The Waterfall Design Model
        1. Stages of the Waterfall Model
          1. Advantages and Limitations
          2. Alternative Models
            1. Agile Development
              1. V-Model
                1. Spiral Model
              2. User Needs and Market Requirements
                1. Stakeholder Analysis
                  1. Voice of the Customer
                    1. Market Research Techniques
                    2. Design Inputs
                      1. Functional Requirements
                        1. Performance Requirements
                          1. Safety Requirements
                            1. Regulatory Requirements
                              1. Usability Requirements
                                1. Environmental Requirements
                                2. Design Outputs
                                  1. Specifications
                                    1. Drawings and Schematics
                                      1. Manufacturing Procedures
                                        1. Device Master Record
                                          1. Bill of Materials
                                          2. Design Reviews
                                            1. Review Stages and Objectives
                                              1. Cross-Functional Team Involvement
                                                1. Documentation of Findings
                                                2. Design Verification
                                                  1. Definition and Purpose
                                                    1. Test Protocols and Reports
                                                      1. Traceability Matrix
                                                        1. Verification Methods
                                                          1. Inspection
                                                            1. Testing
                                                              1. Analysis
                                                            2. Design Validation
                                                              1. Definition and Purpose
                                                                1. Validation in Simulated Use Conditions
                                                                  1. Validation in Actual Use Conditions
                                                                    1. Clinical Evaluation
                                                                      1. Human Factors Validation
                                                                      2. Design Transfer to Manufacturing
                                                                        1. Transfer Planning
                                                                          1. Process Validation
                                                                            1. Training and Documentation
                                                                            2. Design History File
                                                                              1. Contents and Structure
                                                                                1. Maintenance and Updates

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                                                                              4. Medical Device Classification

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                                                                              6. Quality Management Systems