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1. Software Risk Assessment: Additional section for devices with software components, addressing cybersecurity risks

2. Sterility Considerations: For sterile medical devices, including specific sterilization risk assessment

3. Environmental Impact Assessment: For devices with potential environmental impacts or special disposal requirements

4. User Training Risk Assessment: For devices requiring specific user training or certification

5. Clinical Risk Assessment: Detailed clinical risk evaluation for high-risk or novel devices

6. Manufacturing Process Risks: For locally manufactured devices, addressing production-specific risks

1. Appendix A: Risk Assessment Matrices: Detailed risk scoring matrices and evaluation criteria

2. Appendix B: Hazard Checklist: Comprehensive checklist of potential hazards considered

3. Appendix C: Technical Documentation: Relevant technical specifications and drawings

4. Appendix D: Test Reports: Summary of safety and performance testing results

5. Appendix E: Risk Control Verification: Evidence of risk control measure implementation and effectiveness

6. Appendix F: UAE Regulatory Requirements Checklist: Checklist demonstrating compliance with specific UAE medical device regulations

7. Appendix G: Incident Report Template: Template for reporting and analyzing safety incidents

8. Appendix H: Risk Assessment Review Log: Documentation of periodic risk assessment reviews and updates