R-TF-013-004 EN 14971 Checklist
EN ISO 14971:2019 Checklist
This document provides a comprehensive checklist to demonstrate compliance with the requirements of the harmonized standard EN ISO 14971:2019 Medical devices - Application of risk management to medical devices.
4. General requirements for risk management
| Reference | Requirement | Required | Fulfilled in |
|---|---|---|---|
| 4.1 | Risk management process | TRUE | Section Risk management process in document GP-013 Risk management |
| 4.2 | Management responsibilities | TRUE | Section Responsibilities and authorities in document R-TF-013-001 Risk management plan |
| 4.3 | Qualifications of personnel | TRUE | Document Quality Manual, section Human resources and procedure GP-002 Personnel training and skills |
| 4.4 | Risk management plan | TRUE | Document R-TF-013-001 Risk management plan |
| 4.5 | Risk management file | TRUE | All risk management documents are archived in the DHF and technical documentation |
5. Risk analysis
| Reference | Requirement | Required | Fulfilled in |
|---|---|---|---|
| 5.1 | Risk analysis process | - | - |
| 5.2 | Intended use and identification of characteristics related to the safety of the medical device | TRUE | Section Scope in document R-TF-013-001 Risk management plan and section Intended use and identification of the qualitative and quantitative characteristics in R-TF-013-003 Risk management report |
| 5.3 | Identification of hazards | TRUE | Section Hazard identification in document R-TF-013-001 Risk management plan and document R-TF-013-002 Risk management record |
| 5.4 | Estimation of the risk(s) for each hazardous situation | TRUE | Section Risk estimation in document R-TF-013-001 Risk management plan and document R-TF-013-002 Risk management record |
6. Risk evaluation
| Reference | Requirement | Required | Fulfilled in |
|---|---|---|---|
| 6.1 | Risk evaluation | TRUE | Section Risk evaluation in document R-TF-013-001 Risk management plan and section Evaluation in document R-TF-013-002 Risk management record |
7. Risk control
| Reference | Requirement | Required | Fulfilled in |
|---|---|---|---|
| 7.1 | Risk control option analysis | - | - |
| 7.1 | Risk control option analysis | TRUE | Section Risk control in document R-TF-013-001 Risk management plan and sections Risk control measures and Mitigation in document R-TF-013-002 Risk management record |
| 7.2 | Implementation of risk control measures | - | - |
| 7.2 | Implementation of risk control measures | TRUE | Section Risk control measures and Mitigation in document R-TF-013-002 Risk management record |
| 7.3 | Residual risk evaluation | - | - |
| 7.3 | Residual risk evaluation | TRUE | Section Residual risk evaluation in document R-TF-013-001 Risk management plan and section Residual risk in document R-TF-013-002 Risk management record |
| 7.4 | Benefit-risk analysis | - | - |
| 7.4 | Benefit-risk analysis | TRUE | Section Benefit-risk analysis in document R-TF-013-001 Risk management plan and section Benefit-risk ratio acceptability in document R-TF-013-003 Risk management report |
| 7.5 | Risks arising from risk control measures | - | - |
| 7.5 | Risks arising from risk control measures | TRUE | Section Risks arising from risk control measures in document R-TF-013-001 Risk management plan and document R-TF-013-002 Risk management record where new risks introduced by control measures are identified and controlled |
| 7.6 | Completeness of risk control | - | - |
| 7.6 | Completeness of risk control | TRUE | Section Completeness of risk control in document R-TF-013-001 Risk management plan and section Risk management review in document R-TF-013-003 Risk management report |
8. Evaluation of overall residual risk acceptability
| Reference | Requirement | Required | Fulfilled in |
|---|---|---|---|
| 8 | Evaluation of overall residual risk acceptability | TRUE | Section Overall residual risk evaluation in document R-TF-013-001 Risk management plan and section Overall residual risk in document R-TF-013-003 Risk management report |
9. Risk management review
| Reference | Requirement | Required | Fulfilled in |
|---|---|---|---|
| 9 | Risk management review | TRUE | Section Risk management review in document R-TF-013-001 Risk management plan and section Risk management review in document R-TF-013-003 Risk management report |
10. Production and post-production activities
| Reference | Requirement | Required | Fulfilled in |
|---|---|---|---|
| 10.1 | Information collection and review | - | - |
| 10.1 | Information collection and review | TRUE | Section Production and post-production information in document R-TF-013-001 Risk management plan, procedure GP-007 Post-market surveillance, and document R-TF-007-001 Post-market surveillance (PMS) plan |
| 10.2 | Review of information | - | - |
| 10.2 | Review of information | TRUE | Section Production and post-production information in document R-TF-013-001 Risk management plan, procedure GP-007 Post-market surveillance, and documents R-TF-007-002 Post-market surveillance (PMS) report |
| 10.3 | Actions resulting from information review | - | - |
| 10.3 | Actions resulting from information review | TRUE | Procedure GP-023 Change control management, procedure GP-006 Non-conformity, Corrective and Preventive actions, and procedure GP-004 Vigilance system |
Risk management documentation summary
The risk management process for Legit.Health Plus is comprehensively documented across the following key documents:
| Document | Description |
|---|---|
GP-013 Risk management | General procedure defining the risk management process, responsibilities, and methodologies applied throughout the product lifecycle |
R-TF-013-001 Risk management plan | Specific risk management plan for Legit.Health Plus, defining activities, criteria for risk acceptability, and information to be collected |
R-TF-013-002 Risk management record | Detailed record of all identified hazards, hazardous situations, risk estimation, control measures, verification activities, and residual risk evaluation |
R-TF-013-003 Risk management report | Risk management report including intended use analysis, benefit-risk analysis, overall residual risk evaluation, and risk management review |
R-TF-007-001 Post-market surveillance plan | Post-market surveillance plan describing activities for collecting and reviewing production and post-production information |
R-TF-007-002 Post-market surveillance report | Post-market surveillance reports documenting review of production and post-production information and impact on risk management activities |
GP-023 Change control management | Procedure for managing changes that may impact device safety and performance, including risk assessment |
GP-006 Non-conformity, CAPA | Procedure for handling non-conformities, implementing corrective and preventive actions, including risk re-evaluation |
GP-004 Vigilance system | Procedure for identifying, documenting, and reporting incidents and near-incidents, and evaluating their impact on risk management |
Compliance statement
This checklist demonstrates that Legit.Health Plus complies with all applicable requirements of EN ISO 14971:2019 for the application of risk management to medical devices. All requirements have been fulfilled through the comprehensive risk management system documented in the procedures and records listed above.
The risk management process is integrated throughout the entire device lifecycle, from initial concept and design through production, post-market surveillance, and decommissioning. The process is continuously reviewed and updated based on new information from production and post-production activities.
Record signature meaning
- Author: JD-004
- Reviewer: JD-003
- Approval: JD-005