Traceability Matrix
Summary
The Traceability Matrix provides a comprehensive mapping that demonstrates how your user needs flow through system requirements, subsystem requirements, design outputs, and verification/validation activities, ensuring complete coverage and regulatory compliance.
Why is Traceability Matrix important?
The Traceability Matrix is essential for demonstrating that your medical device development process is systematic, complete, and traceable from initial user needs to final verification and validation. It provides regulatory authorities with clear evidence that every user need has been addressed through appropriate requirements, design outputs, and testing activities. This document is crucial for proving that nothing has been overlooked in your development process and that your final device actually meets the needs you identified at the beginning. Without proper traceability, you cannot demonstrate that your device development was controlled and that all requirements have been adequately addressed.
Regulatory Context
Under 21 CFR Part 820 (Quality System Regulation) and Design Controls:
- Design controls require traceability from user needs through design outputs (820.30)
- Design verification must demonstrate that design outputs meet design inputs (820.30(f))
- Design validation must demonstrate that devices meet user needs (820.30(g))
- Design history file must contain traceability documentation (820.30(j))
Special attention required for:
- Class II and III devices requiring comprehensive design control documentation
- Software medical devices requiring traceability through software lifecycle processes
- Combination products requiring coordination between device and drug development traceability
- 510(k) submissions requiring predicate device comparison traceability
Under 21 CFR Part 820 (Quality System Regulation) and Design Controls:
- Design controls require traceability from user needs through design outputs (820.30)
- Design verification must demonstrate that design outputs meet design inputs (820.30(f))
- Design validation must demonstrate that devices meet user needs (820.30(g))
- Design history file must contain traceability documentation (820.30(j))
Special attention required for:
- Class II and III devices requiring comprehensive design control documentation
- Software medical devices requiring traceability through software lifecycle processes
- Combination products requiring coordination between device and drug development traceability
- 510(k) submissions requiring predicate device comparison traceability
Under EU MDR 2017/745 and EN ISO 13485:2016:
- Design and development planning must ensure traceability (ISO 13485 Section 7.3.1)
- Technical documentation must demonstrate traceability (Annex II)
- Risk management traceability required per ISO 14971 integration
- Clinical evaluation must trace clinical evidence to intended use (Article 61)
Special attention required for:
- Notified body assessment of traceability completeness for Class IIa and above
- Post-market surveillance data integration requiring traceability updates
- Clinical evaluation updates requiring traceability to new clinical evidence
- Unique Device Identification (UDI) traceability for device variants
Guide
Your Traceability Matrix must demonstrate complete and systematic traceability from user needs through verification and validation activities. This document serves as the backbone of your design control process, ensuring nothing is missed and everything is properly tested.
Requirements Traceability
Your traceability-matrix table must map each User Need ID to corresponding System Requirements ID and Subsystem Requirements ID. This demonstrates that every user need has been translated into specific, testable requirements. Each requirement should have clear Design Output documentation that shows how the requirement was implemented in your device design.
Verification and Validation Mapping
For each requirement, document the corresponding Verification and Validation activities. Verification demonstrates that your design outputs meet your design inputs (requirements), while validation demonstrates that your device meets user needs and intended use. Reference specific test protocols, test reports, or other verification/validation documents that provide evidence of compliance.
Risk Traceability Integration
Your risk-traceability-matrix table must demonstrate how identified risks flow through your risk management process. Map each Risk ID to its associated Hazard, Hazardous Situation, and potential Harm. Document the Risk Acceptability determination and any Risk Control ID implemented to mitigate unacceptable risks.
Risk Control Implementation Traceability
For risks requiring controls, trace each Risk Control ID to specific Risk Control Requirements ID that were implemented in your design. Provide a clear Description of how the risk control was implemented and reference the Verification activities that demonstrate the risk control is effective.
Completeness Verification
Ensure your traceability matrix has no gaps or blank entries. Every user need should trace through to verification and validation activities. Every unacceptable risk should trace through to implemented and verified risk controls. This completeness is essential for regulatory compliance and demonstrates the thoroughness of your development process.
Example
Scenario: You develop a mobile app for diabetes management that tracks blood glucose levels and provides medication reminders. Your traceability matrix shows how user needs for accurate data tracking and timely reminders flow through system requirements, design implementation, and testing activities. Risk traceability demonstrates how you addressed data security and medication safety concerns.
Traceability Matrix
ID: TM-001
1. Purpose and Scope
The purpose of this document is to provide a traceability matrix for DiabetesTracker Mobile App, developed in compliance with ISO 13485 requirements and ISO 14971 requirements. The traceability matrix provides evidence that regulatory, design, and development requirements are systematically traced to corresponding outputs, including risk management, testing, and verification/validation activities.
2. Traceability Matrix
| User Need ID | System Requirements ID | Subsystem Requirements ID | Design Output | Verification | Validation |
|---|---|---|---|---|---|
| UN-001 | SR-001, SR-002 | SSR-001, SSR-002, SSR-003 | User Interface Design Document | System Test Report Section 3.1 | Usability Evaluation Report Section 4.2 |
| UN-002 | SR-003, SR-004 | SSR-004, SSR-005 | Data Management Architecture | System Test Report Section 3.2 | Clinical Validation Study Report |
| UN-003 | SR-005 | SSR-006, SSR-007 | Notification System Design | System Test Report Section 3.3 | Usability Evaluation Report Section 4.3 |
| UN-004 | SR-006, SR-007 | SSR-008, SSR-009 | Security Architecture Document | Cybersecurity Test Report | Penetration Test Report |
3. Risk Traceability Matrix
| Risk ID | Hazard | Hazardous Situation | Harm | Risk Acceptability | Risk Control ID | Risk Control Requirements ID | Description | Verification |
|---|---|---|---|---|---|---|---|---|
| R-001 | Incorrect glucose data entry | User enters wrong glucose value | Inappropriate medication dosing | Unacceptable | RC-001 | SSR-010 | Input validation with range checking | System Test Report Section 5.1 |
| R-002 | Data breach | Unauthorized access to health data | Privacy violation and identity theft | Unacceptable | RC-002 | SSR-011 | End-to-end encryption implementation | Cybersecurity Test Report Section 2.1 |
| R-003 | Missed medication reminder | Notification system failure | Delayed or missed medication | Unacceptable | RC-003 | SSR-012 | Redundant notification mechanisms | System Test Report Section 5.3 |
| R-004 | App crashes during data entry | Software anomaly during critical operation | Loss of glucose data | Acceptable | - | - | Acceptable risk with data recovery features | System Test Report Section 6.1 |