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1. 1. Document Control Information: Version control, document owner, approval status, and revision history
2. 2. Medical Device Information: Detailed description of the device, intended use, classification according to UAE regulations, and technical specifications
3. 3. Risk Assessment Methodology: Description of risk assessment approach, scoring systems, and acceptance criteria aligned with UAE.S ISO 14971:2019
4. 4. Hazard Identification: Systematic identification of potential hazards throughout the device lifecycle
5. 5. Risk Analysis: Evaluation of identified risks, including probability and severity assessments
6. 6. Risk Control Measures: Description of implemented and planned risk control measures
7. 7. Risk-Benefit Analysis: Assessment of residual risks against medical benefits
8. 8. Overall Risk Evaluation: Summary of risk assessment findings and conclusions
9. 9. Post-Market Surveillance Plan: Procedures for ongoing risk monitoring and assessment
10. 10. Compliance Declaration: Statement of compliance with UAE regulations and applicable standards
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
Healthcare Technology
Medical Devices Manufacturing
Healthcare Services
Pharmaceutical and Biotechnology
Hospital Equipment
Laboratory Equipment
Diagnostic Equipment
Healthcare Consulting
Quality Assurance Services
Regulatory Compliance Services
Quality Assurance
Regulatory Affairs
Clinical Affairs
Product Development
Technical Documentation
Post-Market Surveillance
Risk Management
Compliance
Medical Affairs
Research and Development
Manufacturing
Quality Control
Document Control
Validation
Quality Assurance Manager
Regulatory Affairs Director
Medical Device Safety Officer
Risk Management Specialist
Clinical Safety Manager
Compliance Officer
Medical Device Technical Expert
Quality Management System Auditor
Product Safety Engineer
Regulatory Compliance Specialist
Medical Device Consultant
Healthcare Technology Assessment Manager
Post-Market Surveillance Manager
Medical Device Registration Specialist
Quality Control Supervisor
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