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Risk Management In Medical Devices_1

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Mind Map on the importance of Risk Management
logan.m.wright
Mind Map by logan.m.wright, updated more than 1 year ago More Less
logan.m.wright
Created by logan.m.wright over 8 years ago
logan.m.wright
Copied by logan.m.wright over 8 years ago
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Resource summary

Risk Management In Medical Devices
  1. Regulations
    1. FDA
      1. ISO
        1. Joint Commission
          1. Safe Medical Device Act
          2. Risk Assessment Techniques
            1. Risk Analysis
              1. Risk Evaluation
                1. Risk Control
                2. Medical Equipment Management Plan
                  1. PreventiveMaintenance Procedures
                    1. Recall Plan
                      1. Device Incident Reporting
                        1. Engineering On-Call Policy
                          1. Documentation
                          2. Project Managers
                            1. Engineering Manager
                              1. Risk Manager
                                1. Teamwork
                                2. Risk Managment Activites Survey
                                  1. Statistical Analysis
                                    1. Respondent Analysis
                                    2. Establish Risk Acceptance Criteria
                                      1. Conceptualization
                                        1. Initial Development
                                          1. Design Verification
                                            1. Clinical Validation
                                              1. Pilot Production
                                                1. Manufacturing
                                                  1. Field Monitoring
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