Risk Assessment Medical Device

Risk Assessment Medical Device Template for Belgium

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Key Requirements PROMPT example:

"I need a Risk Assessment Medical Device document for a new Class IIa insulin pump with integrated software that we plan to launch in Belgium by March 2025, with particular focus on software risks and user interface safety."

Document background

The Risk Assessment Medical Device document is a crucial regulatory requirement for medical device manufacturers operating in Belgium and the broader EU market. This assessment is mandatory under the EU Medical Device Regulation (MDR) 2017/745 and its Belgian implementation laws, serving as a fundamental component of the technical documentation required for medical device certification and market access. The document systematically identifies, analyzes, and evaluates potential risks associated with medical devices throughout their lifecycle, from design to disposal. It incorporates specific Belgian regulatory requirements while aligning with EU-wide standards, making it essential for both local compliance and European market access. The assessment must be maintained and updated throughout the device's lifecycle, particularly when new safety information emerges or design changes occur.

Suggested Sections

1. 1. Document Control: Document version, approval status, revision history, and distribution list

2. 2. Executive Summary: Brief overview of the device, assessment scope, and key findings

3. 3. Device Description: Detailed description of the medical device, including intended use, technical specifications, and classification under MDR

4. 4. Risk Assessment Methodology: Description of risk assessment approach, scoring systems, and acceptance criteria

5. 5. Use Scenarios and User Profile: Analysis of intended use scenarios, user groups, and use environments

6. 6. Hazard Identification: Systematic identification of potential hazards throughout device lifecycle

7. 7. Risk Analysis: Detailed analysis of each identified hazard, including probability and severity assessment

8. 8. Risk Evaluation: Evaluation of analyzed risks against acceptance criteria

9. 9. Risk Control Measures: Description of implemented and recommended risk control measures

10. 10. Residual Risk Assessment: Evaluation of remaining risks after control measures implementation

11. 11. Risk/Benefit Analysis: Overall assessment of device benefits against residual risks

12. 12. Conclusions: Final risk assessment conclusions and recommendations

Optional Sections

1. Post-Market Surveillance Plan: Include when the device is already in market or approaching market release, detailing monitoring of real-world performance

2. Software Risk Analysis: Required when the device includes software components

3. Usability Risk Assessment: Detailed analysis of use-related risks, recommended for devices with significant user interaction

4. Biological Risk Assessment: Required for devices with patient contact or biological interactions

5. EMC Risk Assessment: Required for electrical medical devices

6. Sterilization Risk Assessment: Required for sterile medical devices

Suggested Schedules

1. Appendix A: Risk Assessment Matrices: Risk evaluation criteria, probability and severity matrices

2. Appendix B: Hazard Checklist: Comprehensive checklist of considered hazards and their applicability

3. Appendix C: Test Reports: Summary of relevant test results supporting risk assessment

4. Appendix D: FMEA Tables: Detailed Failure Mode and Effects Analysis tables

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

6. Appendix F: References: List of standards, guidelines, and literature used in the assessment

7. Appendix G: Expert Assessments: Any third-party or expert evaluations conducted

8. Appendix H: Device Technical Documentation: Relevant technical specifications and drawings

Authors

Alex Denne

Head of Growth (Open Source Law) @ tiktok��˰� | 3 x UCL-Certified in Contract Law & Drafting | 4+ Years Managing 1M+ Legal Documents | Serial Founder & Legal AI Author

alex.den.21@genieai.co

Relevant legal definitions

Clauses

Relevant Industries

Medical Devices

Healthcare Technology

Pharmaceutical

Biotechnology

Healthcare Services

Medical Research

Medical Manufacturing

Hospital Equipment

Laboratory Equipment

Diagnostic Equipment

Relevant Teams

Quality Assurance

Regulatory Affairs

Research and Development

Product Development

Clinical Affairs

Technical Documentation

Medical Affairs

Engineering

Compliance

Safety and Risk Management

Validation and Verification

Product Management

Relevant Roles

Quality Assurance Manager

Regulatory Affairs Director

Medical Device Safety Officer

Risk Management Specialist

Clinical Safety Manager

Biomedical Engineer

Product Development Manager

Medical Device Consultant

Compliance Officer

Technical Documentation Specialist

Medical Device Assessor

Quality System Manager

Product Safety Engineer

Validation Engineer

Medical Technical Advisor

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