Biomedical Imaging and Instrumentation

  1. Regulatory and Ethical Considerations
    1. Medical Device Regulation
      1. Regulatory Bodies
        1. FDA
          1. Device Classification
            1. Approval Pathways
              1. 510(k) Clearance
                1. Premarket Approval
                  1. De Novo Classification
                2. European Union
                  1. CE Marking
                    1. Medical Device Regulation
                      1. Notified Bodies
                      2. Other International Bodies
                        1. Health Canada
                          1. TGA Australia
                            1. PMDA Japan
                          2. Quality Management Systems
                            1. ISO 13485
                              1. Design Controls
                                1. Risk Management
                                  1. ISO 14971
                                    1. Risk Analysis
                                      1. Risk Control
                                    2. Clinical Evaluation
                                      1. Clinical Trials
                                        1. Post-Market Surveillance
                                          1. Adverse Event Reporting
                                        2. Quality Assurance and Quality Control
                                          1. Equipment Performance
                                            1. Acceptance Testing
                                              1. Commissioning
                                                1. Performance Specifications
                                                2. Routine Quality Control
                                                  1. Daily Checks
                                                    1. Periodic Testing
                                                      1. Preventive Maintenance
                                                      2. Calibration Procedures
                                                        1. Calibration Standards
                                                          1. Traceability
                                                            1. Calibration Intervals
                                                            2. Documentation and Record Keeping
                                                              1. Standard Operating Procedures
                                                                1. Quality Control Records
                                                                  1. Audit Trails
                                                                2. Radiation Safety and Protection
                                                                  1. Radiation Protection Principles
                                                                    1. ALARA Principle
                                                                      1. Justification
                                                                        1. Optimization
                                                                        2. Dosimetry
                                                                          1. Personal Dosimeters
                                                                            1. Film Badges
                                                                              1. TLD Badges
                                                                                1. Electronic Dosimeters
                                                                                2. Area Monitoring
                                                                                  1. Survey Meters
                                                                                    1. Fixed Monitors
                                                                                  2. Shielding and Protection
                                                                                    1. Structural Shielding
                                                                                      1. Personal Protective Equipment
                                                                                        1. Administrative Controls
                                                                                        2. Regulatory Compliance
                                                                                          1. Radiation Safety Programs
                                                                                            1. License Requirements
                                                                                              1. Inspection and Enforcement
                                                                                            2. Patient Safety and Privacy
                                                                                              1. Patient Safety
                                                                                                1. Risk Assessment
                                                                                                  1. Incident Reporting
                                                                                                    1. Safety Culture
                                                                                                    2. Data Privacy and Security
                                                                                                      1. HIPAA Compliance
                                                                                                        1. Data Encryption
                                                                                                          1. Access Controls
                                                                                                          2. Medical Error Prevention
                                                                                                            1. Human Factors Engineering
                                                                                                              1. Fail-Safe Design
                                                                                                                1. Error Reporting Systems
                                                                                                              2. Ethical Issues in Medical Imaging
                                                                                                                1. Research Ethics
                                                                                                                  1. Institutional Review Boards
                                                                                                                    1. Vulnerable Populations
                                                                                                                      1. International Guidelines
                                                                                                                      2. Clinical Ethics
                                                                                                                        1. Incidental Findings
                                                                                                                          1. Overdiagnosis
                                                                                                                            1. Resource Allocation
                                                                                                                            2. Technology Ethics
                                                                                                                              1. Artificial Intelligence Bias
                                                                                                                                1. Algorithmic Transparency
                                                                                                                                  1. Equity of Access
                                                                                                                                  2. Professional Responsibilities
                                                                                                                                    1. Competency Requirements
                                                                                                                                      1. Continuing Education
                                                                                                                                        1. Professional Standards

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                                                                                                                                    10. Advanced Topics and Applications

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                                                                                                                                    1. Fundamentals of Biomedical Engineering