const contentTitle = "R-TF-013-004 Checklist ISO 14971";

R-TF-013-004 Checklist ISO 14971

This checklist provides a comprehensive review of compliance with the ISO 14971:2019 standard for application of risk management to medical devices. The checklist is structured according to the major clauses of the standard and should be completed as part of the quality management system documentation for the device.

Document Information

Field	Value
Product Name	Legit.Health Plus
Version	1.1.0.0
Checklist Prepared By	Saray Ugidos Seman
Checklist Prepared Date	18 November 2025
Checklist Reviewed By	Alfonso Medela
Checklist Review Date
Checklist Approved By	Andy Aguilar
Checklist Approval Date

Purpose

This checklist demonstrates compliance with ISO 14971:2019 "Medical devices — Application of risk management to medical devices" for Legit.Health Plus. The standard specifies a process for a manufacturer to identify hazards associated with medical devices, estimate and evaluate the associated risks, control these risks, and monitor the effectiveness of controls throughout the product lifecycle.

4. General Requirements for Risk Management System

4.1 Risk management process

Reference	Requirement	Required	Fulfilled	Evidence/Comments
4.1	Establish, document and maintain risk management process throughout lifecycle	TRUE	☑	GP-013 Risk management; R-TF-013-001 Risk management plan
4.2	Establish and maintain top management commitment to risk management	TRUE	☑	GP-013 Risk management - Risk management policy; Quality Manual
4.3	Ensure competence of personnel performing risk management activities	TRUE	☑	R-TF-013-001 Risk management plan - Qualification of the risk management team; T-005-002 Personnel card

4.2 Management responsibilities

Reference	Requirement	Required	Fulfilled	Evidence/Comments
4.2	Top management ensures that risk management is part of design and development	TRUE	☑	GP-013 Risk management; GP-012 Design, redesign and development; Quality Manual

4.3 Qualification of personnel

Reference	Requirement	Required	Fulfilled	Evidence/Comments
4.3	Personnel performing risk management activities have appropriate education, training, and experience	TRUE	☑	R-TF-013-001 Risk management plan - Qualification of the risk management team; T-005-002 Personnel card; CVs archived in HR system

4.4 Risk management plan

Reference	Requirement	Required	Fulfilled	Evidence/Comments
4.4 a)	Plan defines scope of risk management activities	TRUE	☑	R-TF-013-001 Risk management plan - Scope section
4.4 b)	Plan assigns responsibilities and authorities for risk management activities	TRUE	☑	R-TF-013-001 Risk management plan - Assignment of responsibilities and authorities
4.4 c)	Plan defines requirements for review of risk management activities	TRUE	☑	R-TF-013-001 Risk management plan - Risk management activities review
4.4 d)	Plan defines criteria for risk acceptability	TRUE	☑	R-TF-013-001 Risk management plan - Criteria for risk acceptability; GP-013 Risk management
4.4 e)	Plan defines verification activities	TRUE	☑	R-TF-013-001 Risk management plan - Verification activities; GP-013 Risk management
4.4 f)	Plan defines activities related to collection and review of production and post-production information	TRUE	☑	R-TF-013-001 Risk management plan - Collection and review of production and post-production information; GP-006, GP-007, GP-014

4.5 Risk management file

Reference	Requirement	Required	Fulfilled	Evidence/Comments
4.5	Establish and maintain risk management file	TRUE	☑	R-TF-013-001 Risk management plan; R-TF-013-002 Risk management record; R-TF-013-003 Risk management report; Design History File

5. Risk Analysis

5.1 Risk analysis process

Reference	Requirement	Required	Fulfilled	Evidence/Comments
5.1	Perform risk analysis	TRUE	☑	R-TF-013-002 Risk management record; GP-013 Risk management

5.2 Intended use and identification of characteristics related to safety

Reference	Requirement	Required	Fulfilled	Evidence/Comments
5.2	Document intended use and identify characteristics related to safety	TRUE	☑	R-TF-012-031 Product requirements specification; R-TF-013-003 Risk management report - Intended use and identification characteristics; Description and specifications document

5.3 Identification of hazards

Reference	Requirement	Required	Fulfilled	Evidence/Comments
5.3	Identify known and foreseeable hazards	TRUE	☑	R-TF-013-002 Risk management record - Hazard identification column
5.3	Consider use errors and reasonably foreseeable misuse	TRUE	☑	R-TF-013-002 Risk management record; R-TF-025-002 Identification of characteristics for safety and possible use errors
5.3	Document hazards in risk management file	TRUE	☑	R-TF-013-002 Risk management record

5.4 Estimation of risk(s) for each hazardous situation

Reference	Requirement	Required	Fulfilled	Evidence/Comments
5.4 a)	Estimate probability of occurrence of harm	TRUE	☑	R-TF-013-002 Risk management record - P1 probability column; GP-013 Risk management
5.4 b)	Estimate severity of harm	TRUE	☑	R-TF-013-002 Risk management record - Severity column; GP-013 Risk management
5.4	Document risk estimation in risk management file	TRUE	☑	R-TF-013-002 Risk management record

6. Risk Evaluation

6.1 Risk evaluation process

Reference	Requirement	Required	Fulfilled	Evidence/Comments
6.1	For each hazardous situation, decide if risk reduction necessary	TRUE	☑	R-TF-013-002 Risk management record - Risk acceptability before risk control column; GP-013 Risk management
6.1	Use risk acceptability criteria from risk management plan	TRUE	☑	R-TF-013-001 Risk management plan - Criteria for risk acceptability; GP-013 Risk management
6.1	Document risk evaluation in risk management file	TRUE	☑	R-TF-013-002 Risk management record

7. Risk Control

7.1 Risk control option analysis

Reference	Requirement	Required	Fulfilled	Evidence/Comments
7.1 a)	Identify and implement risk control measures using appropriate option(s)	TRUE	☑	R-TF-013-002 Risk management record - Risk control measures and Control method selected columns
7.1 b)	Give preference to inherently safe design	TRUE	☑	R-TF-013-002 Risk management record - Control method selected column; GP-013 Risk management
7.1 c)	If inherently safe design not practical, implement protective measures	TRUE	☑	R-TF-013-002 Risk management record - Control method selected column
7.1 d)	If above not sufficient, provide information for safety	TRUE	☑	R-TF-013-002 Risk management record - Control method selected column; IFU; Label

7.2 Implementation of risk control measures

Reference	Requirement	Required	Fulfilled	Evidence/Comments
7.2	Implement risk control measures in design/manufacturing	TRUE	☑	R-TF-013-002 Risk management record - Risk control measures implementation; DHF documents; R-TF-012-043 Traceability Matrix

7.3 Residual risk evaluation

Reference	Requirement	Required	Fulfilled	Evidence/Comments
7.3	Evaluate residual risk after risk control measures applied	TRUE	☑	R-TF-013-002 Risk management record - P2 probability and Risk acceptability after risk control columns
7.3	Decide if residual risk is acceptable	TRUE	☑	R-TF-013-002 Risk management record - Risk acceptability after risk control column; R-TF-013-003 Risk management report

7.4 Benefit-risk analysis

Reference	Requirement	Required	Fulfilled	Evidence/Comments
7.4	If residual risk not acceptable, perform benefit-risk analysis	TRUE	☑	R-TF-013-002 Risk management record - Acceptability of the individual benefit-risk ratio column; R-TF-013-003 Risk management report - Benefit-risk analysis section
7.4	Document benefit-risk analysis in risk management file	TRUE	☑	R-TF-013-003 Risk management report
7.4	Consider medical benefit provided by device	TRUE	☑	R-TF-015-003 Clinical evaluation report; R-TF-013-003 Risk management report

7.5 Risks arising from risk control measures

Reference	Requirement	Required	Fulfilled	Evidence/Comments
7.5	Identify hazards and hazardous situations introduced by risk control measures	TRUE	☑	R-TF-013-002 Risk management record - Assessment of risks arising from risk control measures column
7.5	Assess risks arising from risk control measures	TRUE	☑	R-TF-013-002 Risk management record - Assessment of risks arising from risk control measures column

7.6 Completeness of risk control

Reference	Requirement	Required	Fulfilled	Evidence/Comments
7.6	Review to ensure completeness of risk control	TRUE	☑	R-TF-013-003 Risk management report - Completeness of risk control section; R-TF-013-002 Risk management record - all hazards assessed

8. Evaluation of Overall Residual Risk Acceptability

8.1 Overall residual risk evaluation

Reference	Requirement	Required	Fulfilled	Evidence/Comments
8.1	Decide if overall residual risk is acceptable	TRUE	☑	R-TF-013-003 Risk management report - Overall residual risk evaluation section
8.1	Consider medical benefit of intended use	TRUE	☑	R-TF-013-003 Risk management report; R-TF-015-003 Clinical evaluation report
8.1	If overall residual risk not acceptable, gather further data	TRUE	☑	R-TF-013-003 Risk management report

9. Risk Management Review

9.1 Risk management review before release

Reference	Requirement	Required	Fulfilled	Evidence/Comments
9.1 a)	Review risk management process has been appropriately carried out	TRUE	☑	R-TF-013-003 Risk management report - Risk management review section
9.1 b)	Review overall residual risk is acceptable	TRUE	☑	R-TF-013-003 Risk management report - Overall residual risk evaluation section
9.1 c)	Review appropriate methods in place to obtain production and post-production information	TRUE	☑	R-TF-013-003 Risk management report; R-TF-007-001 PMS plan; GP-006; GP-007; GP-014
9.1	Document risk management review in risk management file	TRUE	☑	R-TF-013-003 Risk management report

10. Production and Post-production Information

10.1 Collection of information

Reference	Requirement	Required	Fulfilled	Evidence/Comments
10.1	Establish and document system to collect production and post-production information	TRUE	☑	R-TF-007-001 PMS plan; GP-006 Non-conformity. Corrective and preventive actions; GP-007 Post-market surveillance; GP-014 Feedback and complaints; GP-004 Vigilance system

10.2 Review of information

Reference	Requirement	Required	Fulfilled	Evidence/Comments
10.2	Review production and post-production information	TRUE	☑	R-TF-007-003 PSUR; R-TF-007-004 PMS report; Annual management review
10.2	Assess if previously unrecognized hazard is present	TRUE	☑	GP-007 Post-market surveillance; R-TF-007-003 PSUR
10.2	Assess if estimated risk(s) is no longer acceptable	TRUE	☑	GP-007 Post-market surveillance; R-TF-007-003 PSUR

10.3 Actions arising from review

Reference	Requirement	Required	Fulfilled	Evidence/Comments
10.3	If previously unrecognized hazard identified, update risk management file	TRUE	☑	GP-006 Non-conformity. Corrective and preventive actions; GP-007 Post-market surveillance; R-TF-013-002 Risk management record is updated as needed
10.3	If risk no longer acceptable, implement corrective or preventive action	TRUE	☑	GP-006 Non-conformity. Corrective and preventive actions; GP-023 Change control management

Summary

Section	Total Items	Fulfilled	Percentage
4. General Requirements	12	12	100%
5. Risk Analysis	10	10	100%
6. Risk Evaluation	3	3	100%
7. Risk Control	16	16	100%
8. Overall Residual Risk Evaluation	3	3	100%
9. Risk Management Review	4	4	100%
10. Production and Post-production	5	5	100%
Total	53	53	100%

Compliance Statement

☑ Full Compliance: All required items have been fulfilled and documented appropriately.

☐ Partial Compliance: Some items remain unfulfilled. See action plan below.

☐ Non-Compliance: Significant items are unfulfilled. Immediate corrective action required.

Key Evidence Documents

The following key documents provide evidence of compliance with ISO 14971:2019:

Risk Management Planning and Documentation

• GP-013 Risk management: General procedure defining the risk management process
• R-TF-013-001 Risk management plan: Product-specific risk management plan
• R-TF-013-002 Risk management record: Complete risk analysis and control documentation
• R-TF-013-003 Risk management report: Risk management review and conclusions

Design and Development

• GP-012 Design, redesign and development: Design control procedure
• R-TF-012-031 Product requirements specification (PRS): Product requirements including safety requirements
• R-TF-012-043 Traceability Matrix: Traceability of requirements to risks and verification
• Design History File (DHF): Complete design documentation including risk control implementation

Usability Engineering

• R-TF-025-001 Usability plan: Usability engineering process plan
• R-TF-025-002 Identification of characteristics for safety and possible use errors: Use-related hazard identification
• R-TF-025-007 Summative evaluation report: Usability validation results

Clinical Evaluation

• R-TF-015-001 Clinical Evaluation Plan: Clinical evaluation planning including benefit-risk considerations
• R-TF-015-003 Clinical evaluation report (CER): Clinical data and benefit-risk analysis

Post-market Surveillance

• GP-006 Non-conformity. Corrective and preventive actions: CAPA system
• GP-007 Post-market surveillance: PMS process
• GP-014 Feedback and complaints: Complaint handling system
• GP-004 Vigilance system: Adverse event reporting
• R-TF-007-001 PMS plan: Post-market surveillance plan
• R-TF-007-003 PSUR: Periodic Safety Update Report
• R-TF-007-004 PMS report: Post-market surveillance report

Quality Management

• Quality Manual: Top management commitment to risk management
• GP-023 Change control management: Management of changes affecting risk

Personnel Qualification

• T-005-002 Personnel card: Personnel qualification records
• CVs: Curriculum vitae of risk management team members

Information for Users

• Instructions for Use (IFU): Safety information for users
• Label: Device labeling including safety information
• R-TF-001-006 IFU and label validation: Validation of information for safety

Action Plan for Non-Conformities

Item Reference	Description	Responsible	Target Date	Status
N/A	No non-conformities identified	N/A	N/A	N/A

Observations and Continuous Improvement Opportunities

While full compliance with ISO 14971:2019 has been achieved, the following observations are noted for continuous improvement:

1. Regular Reviews: Continue to perform annual reviews of the risk management plan as specified in R-TF-013-001.
2. Post-market Data: Maintain vigilance in collecting and analyzing post-market data through the established PMS system.
3. Emerging Hazards: Stay informed about new hazards related to AI/ML technologies and update risk management file accordingly.
4. Team Competence: Continue to invest in training and development of the risk management team.

Approvals

Role	Name	Signature	Date
Checklist Prepared By	Saray Ugidos Seman		18 November 2025
Checklist Reviewed By	Alfonso Medela
Checklist Approved By	Andy Aguilar

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End of ISO 14971 Checklist

Signature meaning

The signatures for the approval process of this document can be found in the verified commits at the repository for the QMS. As a reference, the team members who are expected to participate in this document and their roles in the approval process, as defined in Annex I Responsibility Matrix of the GP-001, are:

• Author: Team members involved
• Reviewer: JD-003, JD-004
• Approver: JD-001