1. Software Risk Analysis: Required only for devices with software components, analyzing specific software-related risks

2. User Interface Assessment: Needed for devices with significant user interaction to assess use-related risks

3. Sterilization Validation: Required for sterile medical devices, addressing sterilization-related risks

4. Clinical Risk Assessment: Necessary for devices requiring clinical evaluation or with direct patient contact

5. Environmental Impact Assessment: Required for devices with potential environmental hazards or specific disposal requirements

6. Post-Market Surveillance Plan: Detailed section required for high-risk devices or those with limited pre-market data

1. Appendix A: Risk Assessment Matrix: Detailed risk scoring matrix and criteria used for risk evaluation

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

3. Appendix C: Test Reports: Summary of relevant safety and performance test results

4. Appendix D: Risk Control Verification: Documentation of verification activities for risk control measures

5. Appendix E: Technical Documentation: Relevant technical specifications and drawings

6. Schedule 1: Regulatory Requirements: Applicable DRAP and international regulatory requirements

7. Schedule 2: Risk Assessment Forms: Completed risk assessment forms and worksheets

8. Schedule 3: Team Qualifications: Detailed qualifications and training records of risk assessment team members