Traceability Matrix
Phase 2
What is a Traceability Matrix?
A traceability matrix is a tool used in medical device development to ensure that all user needs (UNs) are addressed by linking them to specific design input requirements (DIRs) and other development artifacts. It provides a clear and organized way to track the relationships between user needs, design inputs, and verification and validation activities.
Tips on Creating a Traceability Matrix:
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Be specific and detailed: Ensure that each entry in the traceability matrix is clear and detailed. This helps in accurately linking user needs to design inputs and other relevant documents.
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Align with regulatory standards: Make sure the traceability matrix complies with relevant regulatory standards and guidelines. This is crucial for the approval and marketability of the medical device.
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Maintain comprehensive traceability: Use the traceability matrix to link user needs (UNs) to design input requirements (DIRs), design outputs, verification, and validation activities. This ensures that all aspects of the development process are covered and can be traced back to the original user needs.
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Iterative review: Regularly review and update the traceability matrix as the project progresses. This helps in accommodating any changes in user needs, design inputs, or regulatory requirements.
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GOT QUESTIONS?
FAQ about Traceability Matrix
Here are some answers to frequently asked questions about Traceability Matrix.
Why is a traceability matrix important in medical device development?
How do you create a traceability matrix?
Can a traceability matrix be changed during the development process?
What are common challenges in developing a traceability matrix?
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