Medical Device Design and Regulation

  1. Risk Management
    1. Risk Management Plan
      1. Scope and Objectives
        1. Roles and Responsibilities
          1. Criteria for Risk Acceptability
          2. Risk Analysis
            1. Intended Use and Foreseeable Misuse
              1. Identification of Hazards
                1. Biological Hazards
                  1. Mechanical Hazards
                    1. Electrical Hazards
                    2. Estimation of Risk for Hazardous Situations
                      1. Severity Assessment
                        1. Probability Assessment
                      2. Risk Evaluation
                        1. Risk Acceptability Criteria
                          1. Risk-Benefit Analysis
                          2. Risk Control
                            1. Inherent Safety by Design
                              1. Protective Measures in the Device
                                1. Protective Measures in Manufacturing Process
                                  1. Information for Safety
                                    1. Labeling
                                      1. Instructions for Use
                                      2. Verification of Risk Control Measures
                                      3. Evaluation of Overall Residual Risk
                                        1. Aggregation of Residual Risks
                                          1. Benefit-Risk Analysis
                                          2. Risk Management Report
                                            1. Documentation Requirements
                                              1. Review and Approval
                                              2. Production and Post-Production Information
                                                1. Collection of Feedback
                                                  1. Updating the Risk Management File

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                                                6. Quality Management Systems

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                                                8. Materials and Biocompatibility